RESTORE ULTRA

MDR report key: 1950087 · Received December 7, 2010

Report

Report Number: 3004209178-2010-10270
Event Type: Malfunction
Date Received: December 7, 2010
Date of Event: November 26, 2010
Report Date: November 26, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

THE PT WAS UNABLE TO ADJUST STIMULATION. THE PROGRAMMER DISPLAYED THE 'CALL YOUR DOCTOR ICON.' THE IMPLANTABLE NEUROSTIMULATOR WAS IN A POWER ON RESET CONDITION. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

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	59 YR			IMPLANTED:\| EXTENSION: MODEL 37083, LOT# NKC002424V\| EXPLANTED:\| IMPLANTED:\| IMPLANTED:\| PROGRAMMER: MODEL 37742, LOT# NJD059606N\| ACCESSORY: MODEL 37752, LOT# NKA021979N\| EXPLANTED:\| EXTENSION: MODEL 37083, LOT# NKC008752N\| EXPLANTED:\| EXPLANTED:\| IMPLANTED:\| LEAD: MODEL 3998, LOT# V010602\| EXPLANTED:\| IMPLANTED:\| IMPLANTABLE NEURO STIMULATOR: MODEL 37711\| EXPLANTED:\| IMPLANTED:\| IMPLANTED:\| EXPLANTED:\| LEAD: MODEL 3999, LOT# V284899\| LOT# NJH712314H\| IMPLANTED:\| EXTENSION: MODEL 37083, LOT# NKC001976V\| ACCESSORY: MODEL 37752, LOT# NKA141335N\| PROGRAMMER: MODEL 37743, LOT# NKE149254N\| EXPLANTED:\| EXTENSION: MODEL 37083, LOT# NKC008751N