FDA Adverse Event Malfunction Summary report: N

RESTORE ULTRA

MDR report key: 1202092 · Received October 16, 2008

Report

Report Number
3004209178-2008-06604
Event Type
Malfunction
Date Received
October 16, 2008
Date of Event
June 1, 2008
Report Date
September 18, 2008
Manufacturer
MEDTRONIC PUEROT RICO OPERAITONS CO.
Product Code
LGW
PMA / PMN Number
P840001
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
NOT APPLICABLE

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS EXPERIENCING A SHOCKING SENSATION DOWN HER LEG, WHILE THE STIMULATION DEVICE IS TURNED ON AND OFF. THE SENSATION STARTED OCCURRING WITH MORE FREQUENCY IN THE LAST WEEK, THOUGH IT WAS REPORTED THAT SINCE IMPLANT THE POCKET HAD BEEN SORE, AND WHEN PALPATED, WOULD SEND A SHOCKING SENSATION DOWN THE LEG. AN X-RAY CONFIRMED LEAD PLACEMENT WAS FINE AND CONNECTION TO THE IPG LOOKED GOOD. IMPEDANCE CHECKS WITH THE PATIENT WALKING AND SITTING WERE NORMAL AND THERE WERE NO CHANGES WITH POSITION. WHEN THE DEVICE WAS TURNED OFF, THE PATIENT'S PAIN WAS STILL PRESENT. THE PHYSICIAN WAS PLANNING ON REMOVING THE LEADS AND LEAVING THE INS DEVICE IN PLACE. THE PHYSICIAN FELT THE PATIENT'S SYMPTOMS MAY HAVE BEEN DUE TO NEW RSD IN THE AREA OF THE INS OR THE PATIENT MAY ALSO HAVE MS. THE PATIENT HAD LOST FEELING IN HER LEGS AT ONE POINT (NO DATES PROVIDED). AT THE TIME OF THE REPORT, IT WAS UNKNOWN IF THE LEADS HAD BEEN EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RESTORE ULTRA LGW MEDTRONIC PUEROT RICO OPERAITONS CO. 37712 NA

Patients

Seq Age Sex Outcome Treatment
1 29 YR Required Intervention PROGRAMMER: MODEL 37743| IMPLANTED:| LEAD: MODEL 3778| EXPLANTED:| ACCESSORY: MODEL 37752