FDA Adverse Event Malfunction Summary report: N

RESTORE ADVANCED

MDR report key: 3013310 · Received March 20, 2013

Report

Report Number: 3004209178-2013-03991
Event Type: Malfunction
Date Received: March 20, 2013
Report Date: February 28, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V060415, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT EXPERIENCED TELEMETRY, COUPLING AND COMMUNICATION ISSUES AND HADN'T BEEN ABLE TO FEEL STIMULATION OR RECHARGE HER DEVICE SINCE PRIOR TO (B)(6) 2012. AN OVERDISCHARGE WAS SUSPECTED WHICH WAS REPORTEDLY DUE TO PATIENT COMPLIANCE. IT WAS ALSO REPORTED THE LAST TIME THE PATIENT FELT STIMULATION OR HAD A SUCCESSFUL RECHARGING SESSION WAS TWO TO SIX MONTHS PRIOR TO REPORT. THE PATIENT ATTEMPTED TO USE THE ANTENNA LOCATE FEATURE AND IT WAS REPORTED A POWER-ON RESET MESSAGE WAS DISPLAYED ON THE PATIENT'S DEVICE AND THEN IT LED TO A NORMAL RECHARGING SCREEN. IT WAS REPORTED THE PATIENT WAS ABLE TO RECHARGE THE DEVICE BUT COULD NOT TURN ON THERAPY. IT WAS ALSO REPORTED THE PATIENT RECEIVED A WARNING MESSAGE WITH A POWER-ON RESET CONDITION AND A "CALL DOCTOR" SCREEN WAS DISPLAYED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
115699	RESTORE ADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37713

Patients

Seq	Age	Sex	Outcome	Treatment
1	00059 YR