FDA Adverse Event Injury Summary report: N

QUATTRODE

MDR report key: 3001467 · Received March 5, 2013

Report

Report Number: 1627487-2013-12311
Event Type: Injury
Date Received: March 5, 2013
Date of Event: February 12, 2013
Report Date: February 14, 2013
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: K992946
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LET MET ACCEPTANCE CRITERIA. THEREFORE, 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 4 OF 6. REFERENCE MFR REPORT #1627487-2013-12309, 12310, 12311, 12312 AND 12313. IT WAS REPORTED, THE PATIENT WAS SCHEDULED FOR PNS LEAD REVISION (OFF-LABEL USE). DURING THE PRE-OP ASSESSMENT THE PATIENT HAD A FEVER, NAUSEA AND CHILLS. THE PHYSICIAN SUSPECTED INFECTION AND EXPLANTED THE ENTIRE SYSTEM. NOTE THE PATIENT RECEIVED FOUR LEADS FROM THREE DIFFERENT LOT NUMBERS. THE PATIENT ALSO RECEIVED TWO EXTENSIONS FROM TWO DIFFERENT LOT NUMBERS. ALL DEVICES ARE BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
93028	QUATTRODE	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3146	3761161

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention