FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 2910343 · Received January 11, 2013

Report

Report Number: 3004209178-2013-00461
Event Type: Injury
Date Received: January 11, 2013
Report Date: December 18, 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: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 3889-28, LOT# V051753, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007-09-04, PRODUCT TYPE: PROGRAMMER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD HAD THREE BLADDER INFECTIONS SINCE (B)(6) 2012 AND THAT "THE INFECTIONS KEPT COMING BACK." THE PATIENT WAS GETTING TREATMENT FOR THE INFECTIONS. SHE WAS GOING TO SEE HER DOCTOR IN LESS THAN TWO WEEKS TO HAVE THE DEVICE CHECKED AND INFECTIONS FOLLOWED UP ON. TWO DAYS LATER NO STIMULATION SENSATION WAS REPORTED. IT WAS STATED THAT THE PATIENT'S SYMPTOMS WERE NOT AS BAD AS THEY HAD BEEN PRIOR TO IMPLANT BUT THEY WERE WORSE NOW THAT THE STIMULATION WASN'T WORKING. ABOUT TWO AND A HALF WEEKS LATER IT WAS STATED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE/THERAPY BUT WAS WORKING WITH HER DOCTOR TO RESOLVE THE ISSUES. THE APPOINTMENT DATE WAS MARKED AS (B)(6) 2012. IT WAS ALSO STATED THAT THE BATTERY HAD DIED AND THAT THE PATIENT WAS IN THE PROCESS OF GETTING AUTHORIZATION FOR BATTERY REPLACEMENT. IT WAS NOTED THAT INTRAVENOUS PYELOGRAM WAS DONE ON (B)(6) 2013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17914	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention