FDA Adverse Event Injury Summary report: N

RESTORE ULTRA

MDR report key: 1851139 · Received September 30, 2010

Report

Report Number: 3004209178-2010-07447
Event Type: Injury
Date Received: September 30, 2010
Date of Event: September 2, 2010
Report Date: September 2, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE STIMULATOR HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

Description of Event or Problem · 1

THE PT WAS HOSPITALIZED WITH ISSUES UNRELATED TO HER STIMULATOR LAST WEEK. ON THURSDAY (B)(6)2010, THE PT FELL WHILE IN THE HOSPITAL AND LANDED DIRECTLY ON HER STIMULATOR SITE. HER STIMULATOR STOPPED WORKING. THEY ATTEMPTED TO INTERROGATE IT WITH THE PHYSICIAN PROGRAMMER AND THE PT PROGRAMMER WITH NO SUCCESS. A RESET WAS TRIED WITH THE RECHARGER AND THEN THE ANTENNA LOCATOR WAS TRIED; NEITHER WERE SUCCESSFUL. LEAD IMPEDANCES CHECKED OUT WITHIN NORMAL LIMITS. THE PHYSICIAN REPLACED THE STIMULATOR. THE STIMULATOR WAS REPROGRAMMED THE DAY AFTER IMPLANT AND THE PT RECEIVED THE SAME PARASTHESIA AS SHE HAD PRIOR TO HER FALL. THERE WAS REPORTED TO BE NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE ULTRA		LGW	MDT PUERTO RICO OPERATIONS CO., JUNCOS	37712	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Other	ACCESSORY: MODEL 37752, LOT# NKA129604N\| LEAD: MODEL 39286-65, LOT# N211590004\| IMPLANTED:\| PROGRAMMER: MODEL 37743, LOT# NKE132681N\| EXPLANTED: