FDA Adverse Event Injury Summary report: N

INTERSTIM

MDR report key: 2787351 · Received October 15, 2012

Report

Report Number: 3004209178-2012-09176
Event Type: Injury
Date Received: October 15, 2012
Report Date: October 10, 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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3889-28, LOT# V051852, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION. THE PATIENT FELT STIMULATION IN THE RECTAL AREA THAT BECAME VERY PAINFUL WHEN TRYING TO INCREASE. THE PATIENT WAS REPROGRAMMED MULTIPLE TIMES WITHOUT AN IMPROVEMENT IN SYMPTOMS, AND TURNED THE DEVICE OFF. IT WAS LATER REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED IN (B)(6) 2009 BECAUSE IT DID NOT HELP THE PATIENT'S BLADDER SYMPTOMS AND BECAUSE SHE HAD "SHOOTING PAIN IN HER RECTUM AND STILL DID." THE PATIENT WAS TRYING TO FIND OUT WHY SHE CONTINUED TO HAVE PAIN IN HER RECTUM, AND DID NOT KNOW IF THE 'WIRE' HAD BEEN REMOVED AT THE SAME TIME AS THE INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HCP TOLD THE PATIENT EITHER THERE WAS SOME INVOLVEMENT OF A SACRAL NERVE AT THE TIME OF SURGERY OR THE LEAD WIRE IS STILL IN. THE HCP ORDERED A SET OF SPINAL X-RAYS TO SEE IF THE LEAD WAS STILL IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTERSTIM	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3023

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention