FDA Adverse Event Injury Summary report: N

EON-IPG

MDR report key: 1823397 · Received August 25, 2010

Report

Report Number: 1627487-2010-01960
Event Type: Injury
Date Received: August 25, 2010
Date of Event: June 28, 2010
Report Date: June 28, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, 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 WERE REVIEWED AND 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. 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

ON (B)(6) 2006, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT IS WITHOUT STIMULATION. THE PT LOST THEIR PROGRAMMER SEVERAL MONTHS AGO AND DOES NOT REMEMBER HOW LONG IT HAS BEEN SINCE IT WAS RECHARGED; THE CHARGER WILL NOT LOCATE THE IPG. THE REP FOLLOWED-UP TO DISCOVER THAT THE IPG WAS NOT WORKING. THE PHYSICIAN IS PLANNING IPG REPLACEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON-IPG	IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3716	49127

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other