FDA Adverse Event Injury Summary report: N

RESTORE

MDR report key: 2912036 · Received January 11, 2013

Report

Report Number: 3004209178-2013-00500
Event Type: Injury
Date Received: January 11, 2013
Report Date: December 20, 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: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 377760, LOT # J0555078V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377760, LOT # J0555078V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT WORK FOR THE PATIENT. IT WAS NOTED THEY WERE UNABLE TO GET IT PROGRAMMED TO WHERE IT HELPED THEM. THE INS AND ALL RELATED COMPONENTS WERE REMOVED IN 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT IT WAS UNCLEAR WHAT THE COURSE OF EXPLANT WAS BECAUSE IT WAS NOT DONE THROUGH THEIR PRACTICE. THE PATIENT WAS LAST SEEN ON (B)(6)-2011 FOR PROGRAMMING. THE STATUS OF THE EXPLANT WAS UNCLEAR. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17599	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