FDA Adverse Event Injury Summary report: N

RESTORE

MDR report key: 4576468 · Received March 6, 2015

Report

Report Number: 3004209178-2015-04282
Event Type: Injury
Date Received: March 6, 2015
Report Date: February 11, 2015
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: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 377860, LOT# V013677, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377860, LOT# V013677, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

THE PATIENT WAS NOT GETTING ANY THERAPEUTIC EFFECT FROM HER STIMULATOR. THE PATIENT RECHARGED HER DEVICE AND RESUMED HER STIMULATION THERAPY. THE PATIENT WAS CONCERNED THAT HER PUMP IS NOT WORKING DUE TO THE STIMULATOR BECAUSE SHE READ THE DEVICE COULD INTERFERE WITH ONE ANOTHER. THREE YEARS LATER THE PATIENT REPORTED THAT SHE HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM REPLACED WITH A DIFFERENT DEVICE MANUFACTURER SYSTEM, EVEN THOUGH SHE REQUESTED MEDTRONIC. IT WAS SOMETIME AROUND MARCH 2014. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) CONFIRMED THE EXPLANT DATE WAS 04/11/2014. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
156972	RESTORE	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37711

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention