SINGLE EXTENSION

Report

Report Number: 1627487-2010-03345
Event Type: Injury
Date Received: November 23, 2010
Date of Event: September 30, 2010
Report Date: September 29, 2010
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION DIVISION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. 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 3 OF 3. REFERENCE 1627487-2010-03343 AND 1627487-2010-03344. THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG PERCUTANEOUS LEAD AND SINGLE EXTENSION. IT WAS REPORTED THAT SHE FEELS OVERSTIMULATION WHEN RECHARGING HER IPG. IN ADDITION, THE PATIENT IS SAID TO HAVE A TREMOR WHEN THE STIMULATION IS IN OPERATION. WITH RESPECT TO THE OVERSTIMULATION, SEVERAL NONINVASIVE TECHNIQUES WERE ATTEMPTED; HOWEVER, NONE SEEMED TO TOTALLY RECTIFY THE ISSUE. INTERVENTION FOR THE ALLEGED TREMOR CONSISTED OF REPOSITIONING THE PATIENT'S LEAD, BUT THAT PROBLEM PERSISTED AS WELL. THE PATIENT'S IPG WAS SUBSEQUENTLY REMOVED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SINGLE EXTENSION	SPINAL CORD STIMULATION EXTENSION	LGW	ST. JUDE MEDICAL - NEUROMODULATION DIVISION	3386	176413

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention