BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4614177 · Received March 18, 2015

    Report

    Report Number
    3004209178-2015-04984
    Event Type
    Injury
    Date Received
    March 18, 2015
    Report Date
    January 15, 2015
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V260802, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V260802, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SECOND STIMULATOR IMPLANTED. THE PATIENT HAD A BLADDER CONTROL PROBLEM. A SHORT TIME LATER, THE PATIENT TURNED BOTH STIMULATORS OFF. THEY EXPERIENCED PAIN FROM A SHOCKING SENSATION. THEIR BIG TOE WOULD NOT STOP MOVING. THE STIMULATORS WERE EXPLANTED DUE TO THE PAIN AND AN UNRELATED MRI. DURING SURGERY, THE LEADS FRAYED. THREE WIRES REMAINED IMPLANTED AND COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183895 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention