FDA Adverse Event Malfunction Summary report: N

RESTORE ADVANCED

MDR report key: 3844989 · Received June 3, 2014

Report

Report Number: 3004209178-2014-10013
Event Type: Malfunction
Date Received: June 3, 2014
Report Date: May 14, 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: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, 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: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT¿S DEVICE WAS PUSHING THROUGH THE SKIN. IT WAS NOTED THE IMPLANT STARTED PUSHING OUT OF THE SKIN AND POCKET FOLLOWING A FALL A MONTH PRIOR TO CALL. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE TOLD THE PATIENT THEY NEEDED SURGERY AND INTERROGATED THE IMPLANT. IT WAS NOTED THE PATIENT¿S LEADS WERE POSITIONAL AND MOVING DUE TO FLUID. IT WAS REPORTED IT WAS TAKING EVEN LONGER THAN BEFORE TO CHARGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
324004	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	00035 YR