FDA Adverse Event Other Summary report: N

ANS LAMITRODE 88C ELECTRODE

MDR report key: 922815 · Received October 3, 2007

Report

Report Number: 1627487-2007-00023
Event Type: Other
Date Received: October 3, 2007
Date of Event: August 27, 2007
Report Date: October 3, 2007
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: GZB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE 2 OF 2. REFERENCE: DEVICE MANUFACTURER'S # 1627487-2007-00022. DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE ALSO REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSIONS: THE LAMITRODE WAS RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. NO VISUAL ANOMALIES WERE FOUND. ADVANCED NEUROMODULATION SYSTEMS, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCE OF THE PATIENT'S HISTORY TO THE EVENT REPORTED.

Description of Event or Problem · 1

SEE DEVICE MANUFACTURER'S REPORT # 1627487-2007-00022. THE PATIENT RECEIVED AN EON IPG AND LAMITRODE LEAD IN 2007. THIS SYSTEM WAS EXPLANTED ON APPROX TWO MONTHS LATER, AFTER THE PATIENT DEVELOPED AN INFECTION. FOLLOW-UP WITH THE PATIENT FOUND THAT SHE IS RECOVERING FROM THE INFECTION. SHE HAS NOT YET RECEIVED HER NEW SCS SYSTEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANS LAMITRODE 88C ELECTRODE	SPINAL CORD STIMULATOR LEAD	GZB	ADVANCED NEUROMODULATION SYSTEMS, INC.	3289	R64355

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Other