FDA Adverse Event Injury Summary report: N

INTERSTIM

MDR report key: 3790109 · Received May 5, 2014

Report

Report Number: 3007566237-2014-01234
Event Type: Injury
Date Received: May 5, 2014
Report Date: April 14, 2014
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD NEVER HAD THERAPEUTIC EFFECT. SINCE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT ON (B)(6), 2014, THE PATIENT'S SYMPTOMS WERE NOT HELPED BY HER INS AND THEY HAD TRIED ALL 4 PROGRAMS. THE PRIOR INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION BUT BEFORE IT DEPLETED, SHE HAD BETTER RESULTS THAN SHE IS NOW GETTING WITH HER NEW INS. NOW, THE PATIENT WAS UP TOO MUCH AT NIGHT AND IS OFTEN WET. TODAY, THEY ASKED THE HCP (HEALTHCARE PROVIDER) FOR MORE PROGRAMMING OPTIONS BUT THE HCP DIRECTED THEM TO TURN OFF STIM, TRY NOTHING FOR A WHILE AND HE SAID SHE HAD OPTION OF TAKING IT OUT. THE CALLER NOTED DISSATISFACTION WITH THEIR HCP SERVICE. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE EVENT WAS UTI (URINARY TRACT INFECTION).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
266970	INTERSTIM	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC NEUROMODULATION	NEU_INTERSTIM_INS

Patients

Seq	Age	Sex	Outcome	Treatment
1	00070 YR		Required Intervention