RESTORE

MDR report key: 3582487 · Received January 17, 2014

Report

Report Number: 3004209178-2014-00828
Event Type: Injury
Date Received: January 17, 2014
Report Date: December 30, 2013
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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # V013837, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

Description of Event or Problem · 1

IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿DEAD¿ DUE TO PATIENT NON-COMPLIANCE WITH RECHARGING. IT WAS NOTED THE PATIENT HAD MEMORY ISSUES AND THEY NEVER UNDERSTOOD RECHARGING. IT WAS NOTED THE INS WAS REPLACED WITH A PRIMARY CELL DEVICE ON THE DAY OF REPORT.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED NO DIAGNOSTICS WERE PERFORMED. IT WAS NOTED THE PATIENT WAS DOING WELL AND THEY HAD GREAT COVERAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
45297	RESTORE	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37711

Patients

Seq	Age	Sex	Outcome	Treatment
1	00067 YR		Required Intervention