FDA Adverse Event Malfunction Summary report: N

QUATTRODE 3/6 PERCUTANEOUS LEADS

MDR report key: 1883181 · Received October 19, 2010

Report

Report Number: 1627487-2010-02866
Event Type: Malfunction
Date Received: October 19, 2010
Date of Event: September 23, 2010
Report Date: September 23, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO 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 FORM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION 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 PT HAS 2 QUATTRODES. THE ONE ON THE RIGHT IS FINE BUT THE ONE ON THE LEFT HAS HIGH IMPEDANCES (21,530 OHMS) ON ALL CONTACTS. THERE IS NO STIMULATION IN THE LEFT LEAD. X-RAYS SHOW THE CONNECTIONS APPEAR INTACT AND THERE ARE NO VISIBLE BREAKS. THE TERRITORY MGR STATED THAT REPLACING THE LEAD IS THE ONLY OPTION TO CORRECT THIS ISSUE, HOWEVER, HE IS NOT SURE IF/WHEN IT WILL BE SCHEDULED DUE TO THE PT'S FINANCIAL RESPONSIBILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUATTRODE 3/6 PERCUTANEOUS LEADS	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3151	3171885

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other