FDA Adverse Event Injury Summary report: N

GENESIS 8-CHANNEL IPG

MDR report key: 1834164 · Received September 13, 2010

Report

Report Number: 1627487-2010-02044
Event Type: Injury
Date Received: September 13, 2010
Date of Event: January 11, 2008
Report Date: February 14, 2008
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 (B)(6) RECEIVED HER SCS SYSTEM ON (B)(6)2007. IT WAS REPORTED THAT THE PT WAS EXPERIENCING OVERSTIMULATION. THE IPG WAS REPLACED ON (B)(6)2008. F/U ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED 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 8-CHANNEL IPG	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS	3608	68305

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention