RESTORE ULTRA

MDR report key: 1932055 · Received November 30, 2010

Report

Report Number: 3004209178-2010-10050
Event Type: Malfunction
Date Received: November 30, 2010
Date of Event: May 1, 2009
Report Date: November 18, 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: NY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

THE PT HAD A FALL IN BEGINNING OF (B)(6) 2010 AND WAS HOSPITALIZED. THE PT FELL HARD AND AS A RESULT THE IMPLANTABLE NEUROSTIMULATOR (INS) SHIFTED TO THE CENTER OF HER BACK AND IT WAS ON A BONE. THE DEVICE CONTINUED THE SHIFT BACK AND FORTH. SINCE THE FALL, THE PT WAS HAVING A DIFFICULT TIME CHARGING THE INS. THE PT WAS EXPERIENCING BURNING PAIN WHILE RECHARGING; THE PAIN WAS ALONG THE LEAD WIRE IN THE BACK OF THE PT'S HEAD. THE INS HAD BEEN REPROGRAMMED; BUT THE ADJUSTMENTS HAD NOT HELPED AT ALL. THE PT WAS CONCERNED ABOUT THE PLACEMENT OF THE DEVICE. SHE WAS ALSO HAVING PAIN AT THE INS SITE. THE PHYSICIAN WAS NOT WILLING TO TAKE THE STIMULATOR OUT. F/U WITH THE PT'S PHYSICIAN WAS RECOMMENDED. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT 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	44 YR			ACCESSORY: MODEL 37752, LOT# NKA122788N\| EXPLANTED:\| PROGRAMMER: MODEL 37743, LOT# NKE112501N\| EXTENSION: MODEL 37081, LOT# NJB020594V\| IMPLANTED:\| EXPLANTED:\| IMPLANTED:\| LOT# NKF706649H\| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,\| ACCESSORY: MODEL 37752, LOT# NKA116242N\| EXPLANTED:\| IMPLANTED:\| LEAD: MODEL 3778, LOT# V141290006