FDA Adverse Event Injury Summary report: N

ANS OCTRODE LEAD

MDR report key: 908180 · Received September 5, 2007

Report

Report Number: 1627487-2007-00016
Event Type: Injury
Date Received: September 5, 2007
Date of Event: June 1, 2007
Report Date: September 5, 2007
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

SECTION: EVALUATION CODES. METHOD: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: ADVANCED NEUROMODULATION SYSTEMS, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCE OF THE PT'S HISTORY TO THE EVENT REPORTED.

Description of Event or Problem · 1

PT WAS IMPLANTED WITH HIS SYSTEM IN 2004. THE PHYSICIAN STATED THAT WHILE EXPLANTING THE SYSTEM IN 2007, ONE CONTACT FELL OFF OF THE LEAD AND INTO THE PT'S SUBCUTANEOUS TISSUE. THE PHYSICIAN LEFT THE CONTACT IN THE PT. THE EXPLANTED SYSTEM WAS DISCARDED AND NOT RETURNED TO ANS FOR ANALYSIS. FOLLOW-UP ON THE PT FOUND THAT HE IS DOING WELL BUT HAS NOT YET RECEIVED ANOTHER SCS SYSTEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANS OCTRODE LEAD	SPINAL CORD STIMULATOR LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	31806	25152

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Other