FDA Adverse Event Malfunction Summary report: N

RESTORE ADVANCED

MDR report key: 2874190 · Received December 14, 2012

Report

Report Number: 3004209178-2012-11858
Event Type: Malfunction
Date Received: December 14, 2012
Report Date: November 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: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL #(B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A DEVICE WAS "FAULTY." IT WAS ALSO STATED THAT THE PATIENT HADN'T RECHARGED THE DEVICE IN ABOUT 14 MONTHS. THE REPORTER STATED THAT THE PATIENT WOULD LIKE TO HAVE HIS SYSTEM ASSESSED. IT WAS NOTED THAT THE PATIENT MAY ALSO WANT TO HAVE A PAIN PUMP IMPLANTED. FOUR DAYS LATER, IT WAS REPORTED THAT A DEVICE HAD NOT BEEN OPERATIONAL FOR THE LAST 16 MONTHS. IT WAS UNCLEAR HOW LONG AGO THE DEVICE WAS OPERATIONAL. THE REPORTER STATED THAT THE DEVICE WOULD NOT CHARGE OR RECHARGE. IT WAS NOTED THAT PRIOR TO 16 MONTHS AGO THE DEVICE WAS WORKING. IT WAS REPORTED THAT THE PATIENT WANTED TO FIGURE OUT HOW TO FIX IT OR TO HAVE IT TAKEN OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	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