FDA Adverse Event Malfunction Summary report: N

RESTORE ULTRA

MDR report key: 3812180 · Received May 15, 2014

Report

Report Number: 3004209178-2014-09015
Event Type: Malfunction
Date Received: May 15, 2014
Report Date: April 23, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN IMPEDANCE CHECK OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) IT WAS CONFIRMED THAT IMPEDANCES WERE HIGH ON ELECTRODES #3-7. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED USING ELECTRODES 0-2. THE PATIENT STATED THAT THEY WERE RECEIVING UNCOMFORTABLE STIMULATION IN THEIR STOMACH AND RIB AREAS. THEIR PHYSICIAN DISCUSSED WITH THE PATIENT THE POSSIBILITY OF REVISING THEIR SINGLE LEAD. THERE WAS NO FURTHER INFORMATION UPDATES AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291897	RESTORE ULTRA	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37712

Patients

Seq	Age	Sex	Outcome	Treatment
1	00030 YR