FDA Adverse Event Malfunction Summary report: N

GENESIS IMPLANTABLE PULSE GENERATOR

MDR report key: 1870729 · Received September 29, 2010

Report

Report Number: 1627487-2010-02320
Event Type: Malfunction
Date Received: September 29, 2010
Date of Event: January 27, 2010
Report Date: January 27, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL METHOD: 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 COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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

THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2006. IT WAS REPORTED THAT THE PT LOST STIMULATION AND COMMUNICATION FUNCTIONALITY WITH THE IPG. THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2010. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED. THE IPG WAS NOT RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GENESIS IMPLANTABLE PULSE GENERATOR	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS	3608	58663

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention