FDA Adverse Event Other Summary report: N

ANS LAMITRODE 44 LEAD

MDR report key: 922813 · Received October 3, 2007

Report

Report Number: 1627487-2007-00026
Event Type: Other
Date Received: October 3, 2007
Date of Event: August 31, 2007
Report Date: October 3, 2007
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: GZB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE 2 OF 2. REFERENCE MANUFACTURER'S REPORT # 1627487-2007-00025. METHOD - ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS - ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSIONS: THE LAMITRODE LEAD WAS RETURNED INCOMPLETE AND THEREFORE, 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

REFERENCE MANUFACTURER'S REPORT # 1627487-2007-00025. THE PT WAS IMPLANTED WITH AN EON IPG AND A LEAD IN 2007 AS A REVISION TO A PRIOR SCS SYSTEM SHE HAD RECEIVED. IN THE RECOVERY ROOM, THE PT WAS REPORTED AS PARALYZED AND NUMB FROM THE CHEST DOWN. THE PT'S SYSTEM WAS EXPLANTED, AND THE PHYSICIAN PERFORMED A LAMINECTOMY AT T7-8 FOR DECOMPRESSION. THE PT WAS DISCHARGED WITH REPORTEDLY STILL SOME NUMBNESS AND A DEFICIT IN MOVEMENT IN HER FOOT. THE PT LATER RECEIVED ANOTHER LAMINECTOMY AT T9-T11. FOLLOW UP WITH THE PT FOUND THAT MOST SENSORY AND MOTOR FUNCTION HAS RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANS LAMITRODE 44 LEAD	SPINAL CORD STIMULATION LEAD	GZB	ADVANCED NEUROMODULATION SYSTEMS, INC.	3244	83691

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Other