RESTORE ULTRA

MDR report key: 2182318 · Received July 11, 2011

Report

Report Number: 3004209178-2011-05302
Event Type: Malfunction
Date Received: July 11, 2011
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LGW
PMA / PMN Number: P840001
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 PATIENT WAS UNABLE TO ADJUST THE STIMULATION. THE DISPLAY SHOWED "CALL YOUR DOCTOR" ICON WITH AN OUT OF REGULATION (OOR) CONDITION. IMPEDANCE READINGS WERE: ELECTRODE IMPEDANCE TEST 0.7V: 408-969 OHMS; 382(11)-648 OHMS; 504-10000(12) OHMS; 391(13)-1169 OHMS; 504-10000(12) OHMS; 427(15)-10000(12) OHMS; 582-10000(12) OHMS; 591-1719 OHMS; 537-906 OHMS; 531-846 OHMS; 408(0)-10000(12) OHMS; 381(11)-1055 OHMS; 565(1)-10000 ON ELECTRODE 2, 4, 5, 6, 10, 13, AND 15, 391(3)-10000(12) OHMS; 411(4)-1731 OHMS. THERAPY IMPEDANCE: 570 OHMS WITH 0-2+ 1.5V/450PW/40HZ; 438 OHMS WITH 10-11-12+13+ 1.7/450PW/40HZ. IT WAS NOTED WITH WHENEVER THE PATIENT'S BATTERY GOT DOWN TO ABOUT 80 PERCENT CHARGE LEFT ON IT AND PATENT READ THE DEVICE WITH HER PATIENT PROGRAMMER; AN OOR CODE WAS GENERATED. THIS ALSO OCCURRED USING A PHYSICIAN PROGRAMMER. NO SHORTS WERE FOUND, BUT THE #12 ELECTRODE WAS OUT OF LIMITS WITH IMPEDANCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE ULTRA		LGW	MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS	37712	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				IMPLANT DATE:\| PROGRAMMER: MODEL 37743, LOT #NKE101437N\| LEAD: MODEL 3778, LOT V387867016\| EXTENSION: MODEL 37081, LOT #NJB069187V\| IMPLANT DATE:\| LEAD: MODEL 3778, LOT #V387867017\| IMPLANT DATE:\| EXTENSION: MODEL 37081, LOT #NJB032204V\| IMPLANT DATE:\| ACCESSORY: MODEL 37752, LOT # NKA136355N