FDA Adverse Event Death Summary report: N

EONC

MDR report key: 3052201 · Received April 2, 2013

Report

Report Number
1627487-2013-15438
Event Type
Death
Date Received
April 2, 2013
Date of Event
February 5, 2013
Report Date
March 11, 2013
Manufacturer
ST JUDE MEDICAL - NEUROMODULATION
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

SJM HAS LIMITED INFO 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

IT WAS REPORTED THE PT PASSES AWAY ON (B)(6) 2013. THE CAUSE OF DEATH IS CURRENTLY UNK. F/U IS IN PROGRESS TO OBTAIN ADD'L INFO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
133713 EONC SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3688 3538823

Patients

Seq Age Sex Outcome Treatment
1 82 YR Death SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)