FDA Adverse Event Injury Summary report: N

SINGLE 8 EXTENSION, 30 CM

MDR report key: 1622035 · Received February 24, 2010

Report

Report Number: 1627487-2009-00277
Event Type: Injury
Date Received: February 24, 2010
Date of Event: September 22, 2008
Report Date: September 22, 2008
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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. THE TERMINAL END OF THE EXTENSION IS MISSING (WAS FOUND IN IPG HEADER) AND EXTENSION HEADER IS CUT. EXTENSION FAILS CONTINUITY TESTING. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

THE PT RECEIVED HIS SCS SYSTEM ON (B) (6) 2006. IT WAS REPORTED THAT THE LEAD EXTENSION BROKE OFF IN THE IPG HEADER. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG AND EXTENSION ON (B) (6) 2008. THERE IS NO FURTHER INFO AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SINGLE 8 EXTENSION, 30 CM	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC	3386	56009

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention