FDA Adverse Event Malfunction Summary report: N

RESTORE ULTRA

MDR report key: 2930261 · Received January 25, 2013

Report

Report Number: 3004209178-2013-00992
Event Type: Malfunction
Date Received: January 25, 2013
Report Date: January 4, 2013
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: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 3998, LOT# V041365, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# V013615, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. A POWER ON RESET CONDITION (POR) WAS REPORTED ALONG WITH A "CALL YOUR DOCTOR" ICON. THE POR CONDITION WAS CLEARED. IT WAS NOTED THE PATIENT WAS EXPOSED TO A SECURITY GATE WHILE THE DEVICE WAS ON. THE PATIENT EXPERIENCED AN "UNDESIRABLE" OR SHOCKING SENSATION AND DIZZINESS. IT WAS STATED IT FELT LIKE THEY HAD THE FLU AND "THEIR BODY HAD A MIGRAINE, BUT ALL OVER." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
35654	RESTORE ULTRA	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MDT PUERTO RICO OPERATIONS CO	37712

Patients

Seq	Age	Sex	Outcome	Treatment
1