Complaint, MDR concerns preceded TPS consent decree.

Telectronics Pacing Systems, Englewood, CO, Denver District.

Three months before Telectronics Pacing Systems (TPS) submitted to a May 1995 consent decree with FDA over GMP deficiencies, the agency conducted two inspections at its Englewood, CO, headquarters in rapid succession. These inspections, which caught the firm in the midst of both recall and reorganization, zeroed in on complaints and MDRs.

The recently released inspection documents indicated that FDA was preoccupied with the company's handling of complaints as far back as 1990.

The first of these inspections, from Jan. 23, to Feb. 1, 1995, followed up on the firm's recall of its Accufix "J" Atrial lead. The second, Feb. 6-22, 1995, checked on progress made since an inspection the previous summer.

The EIR from the first inspection, conducted by Investigators Elvin Smith and Victor Spanioli, noted that Telectronics had instituted a new code in its complaint system to handle cases of fractured stiffener wire. At that point fractures appeared "randomly distributed," the report said.

The investigators noted that in 1989 there was a noticeable drop in submission of five-day MDRs. They also mentioned disagreement among management on how to report them.

According to the EIR, William Townsend, director, regulatory affairs field performance, said procedural myocardial perforations qualified as five-day MDRs. On the other hand, Mark Allen, manager of product performance, said they were considered malfunctions to be reported quarterly.

MDR deviations were listed in the inspection report, along with deficiencies in failure investigations and corrective actions.

At the second inspection Investigator Jon Curran focused even more sharply on complaints and MDRs. The EIR stated that he found a considerable backlog in processing complaints, despite the hiring of temporary employees.

Investigator queries complaint classification

Examining a sample of the complaint records, Curran found a case where an Atrial J Lead was removed due to performance problems but classified by Telectronics as "elective lead removal." This coding "made the event a non-MDR event," the EIR said. This classification remained unchanged when the company's own analysis confirmed a J wire fracture.

However, that classification did change during the inspection, according to Curran's statements in the EIR.

"It is not clear what prompted TPS to reclassify the event as a (5-day reportable) MDR event on 2/13/95," the EIR continued, "but they did. This coincided with the time I [Curran] was specifically asking them about these types of reporting problems."

Curran also cited other cases in which Telectronics classified a complaint as not MDR-reportable or described a death as unrelated to the device without adequate information on file to support such a decision. The EIR listed several instances where a complaint was classified as "Hold, more information needed," but was not reclassified after analysis of pacers found hermetic seal failure.

The investigator described a "backlog on processing non-death or serious injury MDR reports," which Telectronics blamed on the demand placed on personnel due to the product recall, according to the inspection report.

Further observations cited inadequate review to assure the accuracy of complaint records, failure to prevent unnecessary delay in processing complaints and incomplete collection of data.

As for failure investigations, Curran determined that these were sometimes incomplete because Telectronics did not always try to retrieve a device for analysis, even if it was available, according to the EIR.

Change controls came under scrutiny when Curran found quality assurance did not formally review and approve departmental procedures. As a result, there were inconsistencies in lists of complaint codes and forms used to gather complaint information, the EIR stated.

FDA's concern with holding to a promised time frame for corrections showed up in an observation that Telectronics had yet to implement a standard operating procedure on engineering issues, promised by Jan. 25, 1995. The EIR described this SOP as "collected specifically to check on the progress of TPS corrections."

In addition to the recall, the inspections caught Telectronics in the throes of restructuring. William Thomas, formerly president and CEO, was planning to leave for Australia to assume the position of CEO of Nucleus Ltd., the parent company of Telectronics, the documents said.

James Dennis took over as president effective Jan. 1, 1995. He told Curran he wanted to "shift the power base from Thomas appointees to his own," according to the EIR.

Curran's conversation with Dennis just prior to the close-out discussion, recorded in the EIR, suggests a level of skepticism on FDA's part regarding any assurances Telectronics might offer.

Dennis expressed his wish to "open a dialogue with FDA" before anything "happens," the EIR said. But Curran told him "it was usually the case that companies would want to meet with FDA and promise corrections, but would not really have something of substance to offer . . . and . . . if he wants to open a dialogue with FDA, he must have something substantial to present."

Curran informed management that "they had already received a warning letter, and it was not routine to issue two warning letters in a row. After a warning letter, either further action such as seizure, injunction, and/or prosecution would be considered, or the inspection would 'clear the boards,' so to speak.

"I told them I conducted this inspection to the level I did because I did not think it would 'clear the boards.' They have continued to show a significant lack of GMPs."

Dennis told Curran "it was difficult for him to know what FDA was thinking about Telectronics," according to the EIR. Curran answered that, going by his own experience, the agency's concern and level of "activity does not get any higher." The consent decree followed on May 22, 1995.

Telectronics Pacing Systems, Englewood, CO, 1/23-2/1/95 and 2/6-22/95, 107600M, $18.50. TPS consent decree, 5/22/95, 107401M, $8.50. Please add $15 handling per order, not per document.