RESTORE ULTRA

MDR report key: 2030447 · Received March 9, 2011

Report

Report Number: 3004209178-2011-01795
Event Type: Malfunction
Date Received: March 9, 2011
Date of Event: February 1, 2011
Report Date: February 22, 2011
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PT INDICATED HIS LEADS WERE BROKEN, SO HE HAD NOT BEEN USING THE DEVICE. THE PT STATED THAT HE HAD NOT CHARGED THE DEVICE FOR OVER 6 MONTHS. THE PT HAD THE IMPLANT DONE AND GOT GOOD RELIEF, BUT THEN HAD FUSION SURGERY DONE WHICH CHANGED THE STIMULATION SO THAT HE COULDN'T FEEL IT. THE PT QUIT USING THE STIMULATION SYSTEM, BUT ATTEMPTED TO RECHARGE IT A FEW DAYS AGO. TELEMETRY ISSUES WERE NOTED AND AN OVERDISCHARGE WAS SUSPECTED. THE USE OF THE ANTENNA LOCATOR RESULTED IN A POWER ON RESET (POR) BEING DISPLAYED ON THE RECHARGER FOLLOWED BY THE NORMAL RECHARGING SCREEN. THE TNI CODES AND INSR STATS WERE AS FOLLOWS: TNI: 0 579, 1. 0, 2. 579. INSR STATS: 0 -(B)(6) 2000, 1. (B)(6) 2000, 2. (B)(6) 2011, 8840 SERVICE CODE: 0X0. ADD'L INFO HAS BEEN REQUESTED, A F/U 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	19 YR			EXPLANTED:\| IMPLANTED:\| ACCESSORY: MODEL 37752, LOT# NKA134057N\| PROGRAMMER: MODEL 37743, LOT# NKE137985N\| EXPLANTED:\| IMPLANTED:\| EXTENSION: MODEL 37081, LOT# NJB062491V\| IMPLANTED:\| LEAD: MODEL 3778, LOT# V265170011\| EXPLANTED:\| EXPLANTED:\| LEAD: MODEL 3778, LOT# V229260023\| IMPLANTED:\| EXTENSION: MODEL 37081, LOT# NJB068713V