FDA Adverse Event Malfunction Summary report: N

EON IPG

MDR report key: 1883213 · Received October 20, 2010

Report

Report Number: 1627487-2010-03001
Event Type: Malfunction
Date Received: October 20, 2010
Date of Event: September 21, 2010
Report Date: September 21, 2010
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION DIVISION
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2005. IT WAS REPORTED THAT THE PT LOST STIMULATION ABOUT THREE YEARS AGO FOLLOWING A FALL. THE IPG WAS REPLACED ON (B)(6) 2010 AND EFFECTIVE STIMULATION WAS RECAPTURED. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER ISSUES HAVE BEEN REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON IPG	TOTALLY IMPLANTABLE PULSE GENERATOR	LGW	ST. JUDE MEDICAL - NEUROMODULATION DIVISION	3716	46130A

Patients

Seq	Age	Sex	Outcome	Treatment
1