FDA Adverse Event Injury Summary report: N

QUATTRODE

MDR report key: 2821099 · Received October 25, 2012

Report

Report Number: 1627487-2012-00711
Event Type: Injury
Date Received: October 25, 2012
Date of Event: September 21, 2012
Report Date: October 6, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT 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 INFO 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 3. REFERENCE MFR REPORT # 1627487-2012-00710 AND 1627487-2012-00712. THE PT'S ((B)(6)) THERAPY SYSTEM INCLUDED FOUR PERCUTANEOUS LEADS FROM TWO LOTS AND TWO LEAD EXTENSIONS FROM THE SAME LOT. IT WAS REPORTED THE PT HAD REDNESS AND SWELLING NEAR THE LEAD SITE FOR HER SUB-OCCIPITAL (OFF LABEL) LEADS. ORAL ANTIBIOTICS WERE PRESCRIBED AS TREATMENT; HOWEVER, A YELLOW DISCHARGE WAS SUBSEQUENTLY OBSERVED AT THE AREA IN QUESTION. SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT THE PT'S LEADS. THE PT'S IPG REMAINS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUATTRODE	SCS LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3156	3246901

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Required Intervention	SCS IPG: MODEL UNK