FDA Adverse Event Malfunction Summary report: N

EON MINI RECHARGEABLE IPG

MDR report key: 1963414 · Received December 20, 2010

Report

Report Number: 1627487-2010-03840
Event Type: Malfunction
Date Received: December 20, 2010
Date of Event: November 22, 2010
Report Date: November 22, 2010
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION DIVISION
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 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. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. THE PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH THE CHARGER AND PATIENT PROGRAMMER. A SJM REP REPORTED THAT A REPLACEMENT CHARGER AND MULTIPLE ATTEMPTS TO COMMUNICATE WITH THE IPG WERE UNSUCCESSFUL. THE ISSUES WERE POSITIVELY INDICATIVE OF PREMATURE BATTERY DEPLETION. FOLLOW UP ON THE PATIENT FOUND THAT THE PATIENT WILL BE SCHEDULED TO HAVE THE IPG EXPLANTED AND REPLACED. THE EXPLANT DATE IS UNDETERMINED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON MINI RECHARGEABLE IPG	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ST JUDE MEDICAL - NEUROMODULATION DIVISION	3788	2867471

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention