FDA Adverse Event Malfunction Summary report: N

RESTORE SENSOR

MDR report key: 3872594 · Received June 13, 2014

Report

Report Number: 3004209178-2014-11572
Event Type: Malfunction
Date Received: June 13, 2014
Report Date: May 21, 2014
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

CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS WITH THEIR DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD POSITIONAL STIMULATION, JOLTING IN SOME POSITIONS, AND SENSITIVITY CHANGES. STANDING IN SOME POSITIONS THEY COULD FEEL VIBRATING IN THEIR WHOLE BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
351130	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