FDA Adverse Event Malfunction Summary report: N

RENEW DUAL RECEIVER, 16-CHANNEL

MDR report key: 1645793 · Received March 19, 2010

Report

Report Number: 1627487-2010-00123
Event Type: Malfunction
Date Received: March 19, 2010
Date of Event: February 17, 2010
Report Date: February 19, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED EVENT 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

IT WAS REPORTED THAT THE PT STOPPED RECEIVING STIMULATION. PT WAS REPROGRAMMED, BUT WITH THE SAME OUTCOME. REP TRIED INCREASING THE PULSE WIDTH AND AMPLITUDE TO THE MAXIMUM LEVEL BUT PT STILL DID NOT FEEL ANY STIMULATION. THE PHYSICIAN OPENED THE POCKET AND FOUND THAT ONE OF THE LEADS HAD A NON-FUNCTIONING CONTACT AT THE END THAT INSERTS INTO THE RECEIVER. THE SALES REP WASHED BOTH LEADS WITH STERILE WATER AND THEN USED THE TRIAL CABLE AND WAS ABLE TO CAPTURE PAIN AREAS ON BOTH LEADS. THE DOCTOR IMPLANTED THE PT WITH A NEW EON MINI IPG. THE PT NOW RECEIVES COMPLETE COVERAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RENEW DUAL RECEIVER, 16-CHANNEL	IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3416	128131B

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other