FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 2653226 · Received July 12, 2012

Report

Report Number: 3004209178-2012-05496
Event Type: Injury
Date Received: July 12, 2012
Report Date: June 13, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3093-28 LOT# V050278 SERIAL# IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3037 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3037 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED, THE PATIENT WAS IN PAIN AND FELT A BURNING SENSATION AT THE INTERNAL NEUROSTIMULATOR (INS) IMPLANT SITE. THE INS WAS REMOVED AND RELOCATED FROM THE RIGHT SIDE TO THE LEFT SIDE OF THE PATIENT'S BODY ON (B)(6) 2012. THE PATIENT INDICATED HER DEVICE WAS NEVER TURNED ON POST RELOCATION SURGERY AND SHE HAD TO GO A MONTH WITH THE DEVICE TURNED OFF. IN THAT TIME, SHE HAD A FULL RETURN OF URINARY SYMPTOMS. THE PATIENT INDICATED THAT MANY OF HER PROGRAMS WERE NOT WORKING AND THAT SHE HAD URINARY FREQUENCY. THE PATIENT COULD NOT FEEL STIMULATION UNTIL 1.7 AMPS. THE PATIENT REPORTED PAIN AT THE LEAD SITE AND SHE HAD TO TURN THE INS OFF SHE WAS NOT IN PAIN. SHE ONLY HAD ONE PROGRAM AND WAS MEETING WITH THE MANUFACTURER REPRESENTATIVE FOR ADDITIONAL PROGRAMS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention