FDA Adverse Event Death Summary report: N

EON MINI

MDR report key: 1316236 · Received February 18, 2009

Report

Report Number: 1627487-2009-00004
Event Type: Death
Date Received: February 18, 2009
Date of Event: December 20, 2008
Report Date: January 27, 2009
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: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVAL: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. ANS. INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS. INC, DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

IT WAS REPORTED IN EARLY 2009 THAT PT ARRESTED AND EXPIRED IN HOSPITAL, DUE TO UNK REASON FOUR DAYS PRIOR. BASED ON FOLLOW-UP, PT WAS IMPLANTED WITH SCS SYSTEM IN LATE 2008 FOR TREATMENT OF BILATERAL ARM PAIN. TWO PERCUTANEOUS LEADS WERE USED; ONE LEAD PLACED AT C2-C3; AND THE OTHER LEAD PLACED AT C1-C2, BOTH LEADS WERE SECURED WITH ANCHORS. IT WAS REPORTED THE FOLLOWING DAY, PT WENT TO ER, DIAGNOSED WITH A SUBDURAL HEMATOMA, AND THEN ADMITTED TO HOSPITAL. IT WAS REPORTED THE PHYSICIAN STATED INCIDENT WAS UNRELATED TO THE SCS SYSTEM. IT WAS REPORTED PT WAS SCHEDULED TO BE RELEASED FROM HOSPITAL THE END OF THE WEEK ON THE DAY PRIOR TO ORIGINAL DATE. SCS SYSTEM REMAINED IMPLANTED AT TIME OF PT'S DEATH. ADDITIONAL INFO REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED, IF ADDITIONAL INFO BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EON MINI	IMPLANTABLE PULSE GENERATOR (IPG)	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3788	174168

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death