FDA Adverse Event Death Summary report: N

EON 16-CHANNEL IPG

MDR report key: 1822353 · Received August 26, 2010

Report

Report Number: 1627487-2010-01999
Event Type: Death
Date Received: August 26, 2010
Date of Event: July 27, 2010
Report Date: July 27, 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

METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. THE IPG WAS VISUALLY INSPECTED AND APPEARED DISCOLORED. PEELING PARYLENE AND SCRATCHES ON THE CAN WERE ALSO OBSERVED. THE IPG PASSED THE AUTO TEST AND COMMUNICATION TESTING WITH THE LAB EQUIPMENT AND A PATIENT PROGRAMMER. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE IPG PASSED FUNCTIONAL TESTING. 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) 2006, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT DIED AND THAT THE HOSPITAL WOULD BE RETURNING THE IPG. THE HOSPITAL REPORTED THAT THEY ARE SIMPLY EMPTYING THEIR STORAGE WHICH INCLUDES SEVERAL SJM PRODUCTS. THE DEATH IS NOT BELIEVED TO BE PRODUCT RELATED. THE CAUSE AND DATE OF DEATH ARE UNKNOWN. NO OTHER INFORMATION IS CURRENTLY AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON 16-CHANNEL IPG	IMPLANTABLE PULSE GENERATOR	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC	3716	57620

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death