FDA Adverse Event Injury Summary report: N

EON MINI 16-CHANNEL IPG

MDR report key: 1837152 · Received September 9, 2010

Report

Report Number: 1627487-2010-02545
Event Type: Injury
Date Received: September 9, 2010
Date of Event: August 16, 2010
Report Date: August 16, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR, 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 STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING RANDOM, VARIABLE STIMULATION IN THE LEGS AND AT THE IPG SITE. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT HAD X-RAYS TAKEN ON (B)(6) 2010, WHICH SHOWED A LEAD WAS DISCONNECTED FROM THE CHANNELS IN THE IPG. IT WAS ALSO REPORTED THAT THE PATIENT ALSO HAS SERIOUS DISCOMFORT AT THE ANCHOR SITE, AND BACK PAIN WHEN AMPLITUDE IS INCREASED. A SURGICAL REVISION OF THE SYSTEM OR REPOSITIONING OF THE LEAD WILL TAKE PLACE AT A LATER DATE.

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	2929927

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other