SYNERGY

MDR report key: 1922912 · Received October 22, 2010

Report

Report Number: 6000032-2010-08258
Event Type: Malfunction
Date Received: October 22, 2010
Date of Event: August 1, 2010
Report Date: September 27, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO, MED REL
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON AN OVERSTIMULATION SENSATION OCCURRED. THE PT STATED SHE INCREASED THE STIMULATION TOO MUCH ABOUT 4 MONTHS AGO. PT INDICATED STIMULATION WAS SO STRONG SHE "NEARLY PASSED OUT". THE PT TURNED STIMULATION OFF AND HAD NOT USED IT SINCE. PT WANTED TO START USING STIMULATION AGAIN BUT STATES SHE CANNOT FEEL STIMULATION ON THE RIGHT SIDE. PT INDICATED THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. PT INDICATED SYMPTOMS WERE IN THE LOW BACK ON THE RIGHT SIDE. THE PT WAS HOME AND IN "GOOD" STATUS. IT WAS LATER REPORTED COMPANY REP INDICATED IMPEDANCES WERE CHECKED AND FOUND TO BE HIGH WITH CONTACTS 5-8. PT WAS GETTING SPINAL CORD STIMULATION (SCS) IN LEFT LEG BUT UNABLE TO GET SCS IN RIGHT LEG DUE TO IMPEDANCE LEVELS. PT WAS DECIDING IF SHE WANTED TO HAVE THE LEAD REPLACED. PT WAS FINE. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNERGY		LGW	MDT PUERTO RICO OPERATIONS CO, MED REL	7427	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR			IMPLANTED:\| EXTENSION: MODEL 7489, LOT# NHU014355V\| EXPLANTED:\| EXPLANTED:\| EXTENSION: MODEL 7489, LOT# NHU014357V\| IMPLANTED:\| IMPLANTED:\| EXPLANTED:\| EXPLANTED:\| IMPLANTED:\| PROGRAMMER: MODEL 7435, LOT# NFT029140P\| LEAD: MODEL 3998, LOT# LB4013