FDA Adverse Event Injury Summary report: N

RESTORE ADVANCED

MDR report key: 2918776 · Received January 16, 2013

Report

Report Number: 3004209178-2013-00668
Event Type: Injury
Date Received: January 16, 2013
Report Date: December 26, 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: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID, 377775 LOT# V008543, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377760 LOT# V012045, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377745 LOT# V010660, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377745 LOT# V010634, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT'S DEVICES WERE "NOT WORKING WELL AT ALL." IT WAS STATED, THE PATIENT HAD BEEN IN "CRISIS MODE FOR THE PAST 3 MONTHS". THE PATIENT HAD BEEN IN THE HOSPITAL FROM (B)(6) 2012. IT WAS FURTHER STATED, THE CAUSE FOR THE PATIENT'S ISSUES WAS DUE TO THE "DEVICES NOT OPERATING PROPERLY." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
25031	RESTORE ADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37713

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization