CAPAs and risk analysis flaws net 8-item write up.

Medtronic Neurological, Minneapolis, MN, received an eight-item 483 following a recent audit for incomplete risk analysis and failure to implement CAPA procedures. Also issued was a July 3, 2007, warning letter.

Conducting the audit for the Minneapolis District Office was investigator Timothy Philips. Only the 483 was available at press time.

FDA stated in the 483: "Risk Analysis Reports for SynchroMed pumps and intrathecal catheters have not identified inflammatory mass/granuloma/fibrosis as an actual or potential hazard. This is contrary to the requirements of risk management procedures."

Next, CAPA procedures addressing the investigation of the cause of nonconformities relating to product, processes and the quality system were not implemented. For example, product comment reports were not evaluated as required by the procedure titled "PCR [product comment reporting] CAPA Evaluation Decision Point." These were not ranked by frequency of occurrence, severity and detectability.

In a related observation, the FDAer noted that procedures addressing the identification of CAPAs were not implemented. Specifically, product comment reports were closed with such phrases as "Investigation not required," and "Does not appear to be a product performance issue." In some cases, there was no documented rationale for the lack of corrective action, which is required by SOP, the 483 added.

Complaint handling also was found to be lacking. "Complaint-handling procedures have not been implemented to ensure that all complaints are evaluated to determine whether the complaint should be filed as a medical device report (MDR)."

The report noted that several medical and scientific literature articles were not entered as product comment reports and evaluated for reportability under medical device reporting.

Also, there was no data or statistical analysis to support a conclusion that "inflammatory mass has been reduced ..." as sated in an Oct. 3, 2006, memo from the director of reliability engineering.

As of Dec. 15, 2006, there were an undisclosed number of cases of inflammatory mass/granuloma/fibrosis reported into the PCR system for devices implanted in the U.S. Using that data, FDA determined that the calculated rate of occurrence was over four times grater than the incidence rate reported in a Jan. 19, 2001 "Dear Colleague" letter.

Data compiled for the third quarter of 2002 through the second quarter of 2007 also failed to support a conclusion that inflammatory mass had been reduced.

Further, FDA documents noted that not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems were identified.

For example, there was no C/PAS, CAPA or Watchlist to address ongoing product performance concerns involving inflammatory mass/granuloma/fibrosis.

In a related observation, FDA noted that a correction or removal conducted to reduce a risk to health posed by a device was not reported in writing to FDA.

"In July 2003, a letter with an enclosed 'Educational Brief" was sent to customers. Also enclosed were reprints of two articles published in the December 2002 issue of 'Pain Medicine' and revised labeling for the SynchroMed Technical Manual. The revised labeling included recommendations concerning the recognition, treatment and mitigation of inflammatory mass," the report stated.

The warning letter stated that the "Educational Brief" in question was believed by the firm to be an update to a Jan. 19, 2001, letter that had been reviewed by FDA prior to issuance. The firm did not believe that the new letter was a correction or removal of the previous letter that required additional FDA authorization.

FDA disagreed with this conclusion, the warning letter noted. Although the Educational Brief contained language consistent with the approved labeling in PMA Supplement P860004/S)53, this new labeling had not been previously communicated to doctors whose patients already had a SynchroMed pump implanted within them.

Medtronic Neurological, Minneapolis, MN, 11/21-12/25/06, Doc. 109990M, $5 plus retrieval.

* The Checklist--Medtronic Neurological

* CAPA procedures related to QS flawed

* Actions to prevent recurring problems not taken