FDA Adverse Event Malfunction Summary report: N

RESTORE SENSOR

MDR report key: 2904840 · Received January 9, 2013

Report

Report Number: 3004209178-2013-00374
Event Type: Malfunction
Date Received: January 9, 2013
Date of Event: December 15, 2012
Report Date: December 17, 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: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(4), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED, THERE WAS NO STIMULATION SENSATION. IT WAS ALSO NOTED, THE STIMULATION TURNED OFF TWICE THE SATURDAY BEFORE REPORT AND AGAIN THE NIGHT BEFORE REPORT AND THE PATIENT WAS UNABLE TO TURN THE DEVICE ON OR FEEL STIMULATION. PATIENT USED THE PATIENT PROGRAMMER TO TURN STIMULATION SETTING UP TO "580, WHICH WAS MUCH HIGHER THAN THEY HAD IT SET BEFORE AND THEY STILL COULD NOT FEEL STIMULATION AND WERE IN PAIN." FOLLOW UP REPORTED, THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THERE WAS AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
12899	RESTORE SENSOR	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37714

Patients

Seq	Age	Sex	Outcome	Treatment
1	00069 YR