FDA Adverse Event Injury Summary report: N

RESTORE ULTRA

MDR report key: 4252093 · Received November 14, 2014

Report

Report Number: 3004209178-2014-21653
Event Type: Injury
Date Received: November 14, 2014
Report Date: October 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: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS AN OVERDISCHARGE AND THE PHYSICIAN MODE RECHARGE (PMR) DID NOT SUCCESSFULLY RESET THE DEVICE. IT WAS NOT KNOWN IF THERE WERE PRIOR OVERDISCHARGES. THE PATIENT WAS VERY FORGETFUL AND FORGOT TO RECHARGER THE BATTERY QUITE A BIT. THE PATIENT MADE MULTIPLE ATTEMPTS AT TRYING TO BRING THE BATTERY BACK TO LIFE BUT WAS UNSUCCESSFUL AND OPTED TO GO TO A NON-RECHARGEABLE BATTERY. ACTIONS AS A RESULT OF THE EVENT INCLUDED REPLACEMENT. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED (B)(6) 2014. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE EVENT OCCURRED DURING NORMAL USE. AFTER REPLACEMENT, THE PATIENT HAD A BIG SMILE ON HER FACE AND WAS DOING GREAT. THE PATIENT STATED IT WAS NICE TO FEEL THE TINGLING AGAIN. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
736730	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			Required Intervention