FDA Adverse Event Malfunction Summary report: N

GENESIS XP 8-CHANNEL IPG

MDR report key: 1904337 · Received October 28, 2010

Report

Report Number: 1627487-2010-02377
Event Type: Malfunction
Date Received: October 28, 2010
Date of Event: July 8, 2008
Report Date: July 10, 2008
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
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 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 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 PATIENT (B)(6) RECEIVED THEIR SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNUSUAL STIMULATION SENSATIONS AND INTERMITTENT STIMULATION. THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2009. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GENESIS XP 8-CHANNEL IPG	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS	3609	118683

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention