FDA Adverse Event Malfunction Summary report: N

RESTORE ULTRA

MDR report key: 2885139 · Received December 26, 2012

Report

Report Number: 3004209178-2012-12212
Event Type: Malfunction
Date Received: December 26, 2012
Report Date: December 7, 2012
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

PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3550-29 LOT# N307860, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT NEEDED TO HAVE SURGERY AGAIN FOR HIS NEUROSTIMULATOR AS HIS LEADS HAD MIGRATED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEADS HAD "SCREWED DOWN AND WERE NO LONGER INSIDE THE HEAD." IT WAS UNCLEAR IF THIS REFERRED TO MIGRATION OF THE LEADS. IT WAS REPORTED THAT THE DEVICE HAD BEEN TURNED OFF. IT WAS NOTED THAT THE PATIENT WANTED A REVISION BUT WAS HAVING PROBLEMS GETTING APPROVAL THROUGH HIS HEALTH INSURANCE. IT WAS REPORTED THAT IF "HE COULDN'T GET IT FIXED" THE DEVICE WOULD BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	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