FDA Adverse Event Malfunction Summary report: N

OCTRODE 8 PERCUTANEOUS LEAD

MDR report key: 1791814 · Received August 4, 2010

Report

Report Number: 1627487-2010-01943
Event Type: Malfunction
Date Received: August 4, 2010
Date of Event: June 23, 2010
Report Date: June 25, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEAD WAS VISUALLY INSPECTED AND BROKEN WIRES WERE NOTED 6 CM FROM THE TERMINAL END. THE LEAD FAILED CONTINUITY TESTING AND SEVERAL CHANNELS ON THE LEAD MEASURED OPEN. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED. AS RECEIVED, THE LEAD FAILED FUNCTIONAL TESTING. THE LEAD SEGMENT HAS SEVERAL CUTS AND BROKEN WIRES. 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. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT LOST STIMULATION. THE SALES REP MET WITH THE PT AND TRIED SEVERAL TROUBLE SHOOTING TECHNIQUES, BUT WAS UNABLE TO RECAPTURE THE PT¿S STIMULATION. FURTHER INVESTIGATION REVEALED THAT 3 OF THE LEAD¿S WIRES WERE BROKEN. THE LEAD WAS REPLACED AND THE PT IS CURRENTLY RECEIVING SATISFACTORY STIMULATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE 8 PERCUTANEOUS LEAD	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3186	3088700

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Other