FDA Adverse Event Malfunction Summary report: N

OCTRODE 8 PERCUTANEOUS LEAD

MDR report key: 1881452 · Received October 8, 2010

Report

Report Number: 1627487-2010-02695
Event Type: Malfunction
Date Received: October 8, 2010
Date of Event: September 5, 2010
Report Date: September 9, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WV, 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 FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 2 OF 2. PLEASE SEE MFR REPORT #1627487-2010-02792 FOR DEVICE 2. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT WAS WITHOUT STIMULATION. THE PT PROGRAMMER AND CHARGER NO LONGER COMMUNICATE WITH THE IPG AND THE PT IS UNABLE TO TURN THE DEVICE ON. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT'S X-RAY'S REVEALED THAT ONE OF THE LEADS HAD PULLED OUT OF THE EPIDURAL SPACE. ON (B)(6) 2010, IT WAS REPORTED THAT THE SYSTEM WOULD BE REPLACED ON (B)(6) 2010 AND THAT THE PT WILL BE IMPLANTED WITH A PADDLE LEAD.

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	3093077

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other