FDA Adverse Event Injury Summary report: N

WIDE-SPACED QUATTRODE PERCUTANEOUS LEADS

MDR report key: 1800781 · Received August 12, 2010

Report

Report Number: 1627487-2010-01865
Event Type: Injury
Date Received: August 12, 2010
Date of Event: July 12, 2010
Report Date: July 12, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND 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. 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

ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE SYSTEM WAS IMPLANTED FOR LOW BACK PAIN. THE PT COMPLAINED OF UNCOMFORTABLE, INTERMITTENT AND RANDOM POCKET STIMULATION. LEAD IMPEDANCES WERE CHECKED AND WERE ALL FINE. THE DOCTOR REVISED THE PT AND OBSERVED THAT THE INSULATION OF THE QUATTRODE LEAD WAS BROKEN/BENT WHERE THE LEAD EXITED THE EXTENSION HEADER (ABOUT 1" BEYOND). THE PT DID NOT REPORT DOING ANYTHING THAT WOULD HAVE CAUSE THE OBSERVED BEHAVIOR. THE DOCTOR REPLACED THE LEAD AND THE NEW LEAD WAS OPERATING FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	WIDE-SPACED QUATTRODE PERCUTANEOUS LEADS	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC	3166	2898526

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other