FDA Adverse Event Injury Summary report: N

RESTORE

MDR report key: 4707844 · Received April 20, 2015

Report

Report Number: 3004209178-2015-07550
Event Type: Injury
Date Received: April 20, 2015
Report Date: March 26, 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: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID: 377745, LOT# V002679, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377745, LOT# V002679, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 377745, LOT# V002679, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377745, LOT# V002679, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140 SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT ¿THEY HAD TO PUT HOLES IN MY SPINE AND SUTURE IT BECAUSE IT KEPT MOVING.¿ THIS WAS NOTED TO HAVE OCCURRED IN 2006 AND THEY HAD TO GO IN 3 TIMES BECAUSE IT KEPT MOVING. FOLLOW-UP WAS PERFORMED TO DETERMINE IF ANY TROUBLESHOOTING HAD OCCURRED, IF A CAUSE HAD BEEN FOUND, AND IF THE ISSUE HAD BEEN RESOLVED FOR THIS HISTORICAL EVENT. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
259971	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