FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 3822078 · Received May 20, 2014

Report

Report Number: 3004209178-2014-09322
Event Type: Injury
Date Received: May 20, 2014
Report Date: April 28, 2014
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: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V021873, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V021873, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V021873, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3889-28, LOT# V021873, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

Description of Event or Problem · 1

IT WAS INDICATED THAT PATIENT WAS IMPLANT IN 2007 OR 2008 AND ABOUT 2 YEARS FOLLOWING THIS SHE HAD TO HAVE ALL COMPONENTS REPLACED BECAUSE "THE WIRES WERE FRIED" AND THEY WERE "COMPLETELY GONE". A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT WAS ALSO REPORTED UNDER MANUFACTURER REPORT # 3004209178-2014-09321 .

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
299793	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	00043 YR		Required Intervention