FDA Adverse Event Malfunction Summary report: N

EON IMPLANTABLE PULSE GENERATOR

MDR report key: 1870681 · Received September 29, 2010

Report

Report Number: 1627487-2010-02190
Event Type: Malfunction
Date Received: September 29, 2010
Date of Event: July 29, 2008
Report Date: September 29, 2008
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
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. AS RECEIVED, IPG HAS INSTRUMENT MARKS ON ANTENNA SILICON. IPG PASSES ALL FUNCTIONAL TESTS. CONCLUSION: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. (B)(4). 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

THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT DURING A REVISION PROCEDURE ON (B)(6) 2008, THE IPG WAS EXPLANTED AND REPLACED BECAUSE, THE PHYSICIAN NOTICED SURFACE SCRATCHES. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON IMPLANTABLE PULSE GENERATOR	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS	3716	97932

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention