FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 2892849 · Received December 28, 2012

Report

Report Number: 1627487-2012-15134
Event Type: Injury
Date Received: December 28, 2012
Date of Event: December 4, 2012
Report Date: December 4, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER'S EVALUATION: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NON CONFORMANCE RELATED TO THE PRODUCT. HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE, AND PRODUCT INTEGRITY AND FUNCTIONALITY MET THE FINAL ACCEPTANCE CRITERIA. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 2 OF 4. REFERENCE MFR REPORT: 1627487-2012-15133, 15135, 15136. THE PT HAD TWO ANCHORS FROM THE SAME LOT NUMBER. IT WAS REPORTED, THE PT DEVELOPED AN INFECTION SUBSEQUENT TO HAVING HER SCS SYSTEM EXPLANTED. THE PT WAS TREATED WITH KEFLEX. FOLLOW UP INFORMATION IDENTIFIED THE INFECTION HAS HEALED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3186	2831905

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR		Required Intervention