FDA Adverse Event Malfunction Summary report: N

RESTORE ADVANCED

MDR report key: 3724884 · Received April 3, 2014

Report

Report Number: 3004209178-2014-05590
Event Type: Malfunction
Date Received: April 3, 2014
Report Date: March 13, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377845, LOT # V017666, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 399930, LOT # V010129, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT RIGHT AFTER IMPLANT IN (B)(6) 2007 THERE WAS A COUPLE OF BANDS ON THE THIRD LEAD THAT SHORTED OUT RIGHT AWAY. IT WAS NOTED THAT A COUPLE OF THEM WEREN¿T WORKING BUT THE PATIENT HAD OTHER PROGRAMS THAT WERE GOOD. IT WAS NOTED THAT THE DEVICE WORKED REAL WELL FOR HIM AND IT FELT GOOD.

Description of Event or Problem · 1

IT WAS REPORTED THAT A COUPLE OF THE ELECTRODES SHORTED AT IMPLANT. IT WAS NOTED THE PATIENT¿S THERAPY WAS GIVING HIM PAIN COVERAGE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF INITIAL REPORT. ADDITIONAL INFORMATION WAS REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
200933	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	00050 YR