FDA Adverse Event Injury Summary report: N

EON 16-CHANNEL IPG

MDR report key: 1611638 · Received February 18, 2010

Report

Report Number: 1627487-2010-00035
Event Type: Injury
Date Received: February 18, 2010
Date of Event: January 5, 2010
Report Date: January 20, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE IPG PASSED COMMUNICATION TESTING WITH THE PT PROGRAMMER AND THE AUTO TEST. CONCLUSION: THE CLAIM REGARDING INVALID READINGS AND NO STIMULATION COULD NOT BE CONFIRMED. NO LEADS WERE RETURNED. THE IPG PASSED THE AUTO TEST AND APPEARS IN FAIR CONDITION. 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

DEVICE 1 OF 3. (REFER TO MFR'S REPORT# 1627487-2010-0036 AND 1627487-2010-0062 FOR DEVICES 2 AND 3 RESPECTIVELY). PT REPORTED NO STIMULATION IN LEFT ARM. UPON INTRA-OP TESTING, 2 OUT OF THE 3 IMPLANTED LEADS HAD INVALID READINGS. THE PHYSICIAN REVISED THE IPG AND LEFT ALL THREE LEADS IN PLACE (1 FUNCTIONING, 2 NON-FUNCTIONING) AND ADDED A FOURTH LEAD. THE TWO WORKING LEADS CONNECTED TO AN EXTENSION AND PLUGGED INTO THE IPG. DOCTOR USED NON-FUNCTIONING 4146 TO PLUG UP THE OTHER PORT IN THE NEW IPG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON 16-CHANNEL IPG	IMPLANTABLE PULSE GENERATOR (IPG)	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3716	48960

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other