RESTORE ULTRA

MDR report key: 1923267 · Received November 9, 2010

Report

Report Number: 3004209178-2010-09111
Event Type: Malfunction
Date Received: November 9, 2010
Date of Event: January 1, 2010
Report Date: October 19, 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: MN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION FROM THEIR DEVICE, AS WELL AS "SPASMS" IN THE DEVICE POCKET AREA AND LEGS. IT WAS STATED THAT PALPATING THE AREA CAUSED THE SPASMS TO STOP TEMPORARILY, BUT THEY RETURNED. IT WAS STATED THE SYMPTOMS HAD BEEN OCCURRING FOR "SEVERAL MONTHS." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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	69 YR			LEAD: MODEL 3487A, LOT# V120460\| EXPLANTED:\| EXPLANTED:\| EXPLANTED:\| IMPLANTED:\| EXPLANTED:\| IMPLANTED:\| LEAD: MODEL 3887, LOT# V116210\| IMPLANTED:\| ACCESSORY: MODEL 37752, LOT# NKA114284N\| EXPLANTED:\| EXPLANTED:\| EXPLANTED:\| EXTENSION: MODEL 37082, LOT# NKB013634N\| IMPLANTED:\| EXTENSION: MODEL 37082, LOT# NKB013626N\| EXPLANTED:\| LEAD: MODEL 3487A, LOT# V120460\| IMPLANTED:\| IMPLANTED:\| IMPLANTED:\| PROGRAMMER: MODEL 37743, LOT# NKE104873N\| LEAD: MODEL 3887, LOT# V116210\| IMPLANTED: