INTERSTIM II

MDR report key: 2913059 · Received January 14, 2013

Report

Report Number: 3004209178-2013-00506
Event Type: Injury
Date Received: January 14, 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: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID, 3889-28 LOT# V510026, IMPLANTED: 2010 (B)(6), EXPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS IMPEDANCE FAILURE IN THE LEADS. THERE WERE IMPEDANCE MEASUREMENTS OF GREATER THAN 4000 IN THE LEADS ON (B)(6) 2011. THE LEADS AND IMPLANTABLE NEUROSTIMULATOR WERE REPLACED ON (B)(6) 2011. IT WAS NOTED THAT THE ETIOLOGY WAS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. IT WAS REPORTED THAT SIGNS AND SYMPTOMS INCLUDED LACK OF EFFICACY AND THE SEVERITY WAS MILD. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2011. THREE WEEKS LATER, IT WAS REPORTED THAT EFFICACY WAS REDUCED FROM THERAPEUTIC LEVEL. SIGNS AND SYMPTOMS INCLUDED INCREASED URGENCY, FREQUENCY, AND INCONTINENCE. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20200	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	00080 YR		Required Intervention