FDA Adverse Event Injury Summary report: N

RESTORE ULTRA

MDR report key: 2418366 · Received January 17, 2012

Report

Report Number: 3004209178-2012-00301
Event Type: Injury
Date Received: January 17, 2012
Report Date: December 27, 2011
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

LEAD: MODEL 3998, LOT #V013862, IMPLANTED: (B)(6) 2007; EXTENSION: MODEL 3708240, SERIAL #(B)(4), IMPLANTED: (B)(6) 2007, RECHARGER: MODEL 37752, SERIAL # (B)(4), PROGRAMMER: MODEL 37743, SERIAL # (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THERE WERE COUPLING AND/OR COMMUNICATION ISSUES WHILE RECHARGING. THE DEVICE HAD BEEN IMPLANTED A FEW WEEKS PRIOR AND THE DEVICE STILL HAD "PUFFINESS" OVER IT. A WEEK LATER THE PATIENT STILL HAD COMMUNICATION ISSUES WHILE RECHARGING. TWO DIFFERENT RECHARGERS WERE USED, BUT THE COMMUNICATION ISSUES PERSISTED. THE REPORTER STATED SINCE THE DEVICE WAS IMPLANTED THE PATIENT HAD NEVER RECEIVED MORE THAN 2 COUPLING BOXES WHILE RECHARGING AND AT THE TIME NO BOXES WERE SHADED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND WAS ABLE TO CHARGE THE DEVICE, BUT CHARGING TOOK A "VERY" LONG TIME. THE PATIENT WAS ADVISED TO CONTINUE MONITORING THE SITUATION. LATER IT WAS REPORTED THE DEVICE WAS FLIPPED. A REVISION WAS PERFORMED DURING WHICH THE DEVICE WAS TACKED DOWN AND ALL CONNECTIONS WERE CHECKED. IMPEDANCES WERE MEASURED AND THE RESULTS WERE WITHIN NORMAL LIMITS. FOLLOWING THE REVISION THE PATIENT WAS ABLE TO RECHARGE WITH ALL 8 COUPLING BOXES, AND THE PATIENT WAS DOING "GREAT."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE ULTRA	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MDT PUERTO RICO OPERATIONS CO	37712

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention