FDA Adverse Event Malfunction Summary report: N

GENESIS 8-CHANNEL IPG

MDR report key: 1791829 · Received August 4, 2010

Report

Report Number: 1627487-2010-01963
Event Type: Malfunction
Date Received: August 4, 2010
Date of Event: April 23, 2010
Report Date: April 23, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION 2 OF 2. PLEASE SEE MFR REPORT #1627487-2010-01808 FOR EVALUATION OF DEVICE 1. EVALUATION: METHOD: COMMUNICATIONS AND FUNCTIONAL TESTING WERE PERFORMED ON THE IPG AFTER A VISUAL INSPECTION. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: NO VISIBLE ANOMALIES WERE NOTED. THE IPG SUCCESSFULLY COMMUNICATED WITH THE PT PROGRAMMER ALTHOUGH, THE WARNING ¿IPG BATTERY LOW¿ WAS VISIBLE. THIS FLAG DID NOT RETURN AFTER THE DEVICE UNDERWENT THE PULSE LOAD TEST. BOTH THE PULSE LOAD TEST AND THE AUTOTEST WERE PASSED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CLAIM ABOUT ¿NO STIMULATION,¿ COULD NOT BE CONFIRMED. 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

DEVICE 2 OF 2. PLEASE SEE MFR REPORT #1627487-2010-01808 FOR DEVICE 1.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GENESIS 8-CHANNEL IPG	IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3608	115814

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other