FDA Adverse Event Malfunction Summary report: N

RESTORE SENSOR

MDR report key: 2933305 · Received January 29, 2013

Report

Report Number: 3004209178-2013-01080
Event Type: Malfunction
Date Received: January 29, 2013
Date of Event: January 1, 2012
Report Date: January 29, 2013
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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 389033, LOT# J0306763V, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING, BUT THAT THE ENTIRE EVENT WAS PREVIOUSLY REPORTED IN THE RELATED MFR. REPORT # 3004209178-2012-04549. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN THIS ZREPORT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED AND THE PATIENT REPORTED NO CHANGE. NO OTHER DIAGNOSTICS WERE PERFORMED. THE PATIENT WAS EVENTUALLY REVISED AFTER ADMITTING SHE 'DID NOT LIKE TO BE BOTHERED WITH RECHARGING.' SHE ALSO REPORTED PAIN WITH RECHARGING. THE PATIENT'S MANAGING PHYSICIAN DETERMINED THAT THE PAIN WAS DUE TO THE PLACEMENT OF THE STIMULATOR OVER THE SCIATIC NERVE. ANY ADDITIONAL INFORMATION WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
39751	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	00060 YR		Required Intervention