FDA Adverse Event Malfunction Summary report: N

EON MINI 16-CHANNEL IPG

MDR report key: 1881409 · Received October 7, 2010

Report

Report Number: 1627487-2010-02791
Event Type: Malfunction
Date Received: October 7, 2010
Date of Event: September 8, 2010
Report Date: September 8, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS 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) 2008, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT LOST STIMULATION. THE PT IS UNABLE TO FEEL THE STIMULATION AT MAX AMPLITUDE, UNLESS HE PUSHES ON THE IPG. THE IPG HAS NO ISSUES COMMUNICATING WITH THE PROGRAMMER AND CHARGER. AN X-RAY WAS TAKEN BUT DID NOT REVEAL ANY ANOMALIES. ON (B)(6) 2010, IT WAS REPORTED THAT THE STIMULATION IS AFFECTED BY POSITIONAL CHANGES AND AT TIMES CAN SURGE STRONGLY TO AN UNCOMFORTABLE LEVEL. IT IS UNK AT THIS TIME WITH THE NEXT COURSE OF ACTION WILL BE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON MINI 16-CHANNEL IPG	IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3788	176166

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other