BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3629186 · Received February 14, 2014

    Report

    Report Number
    3004209178-2014-03038
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V132957, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT PROCEDURE FOR THE IMPLANTABLE NEUROSTIMULATOR (INS), THE PHYSICIAN USED THE TORQUE WRENCH AND HEARD THE ¿CLICK¿. IT WAS THEN REPORTED THAT THE LEAD COMPONENT CAME OUT OF THE INS AND, AFTER MULTIPLE CLICKS, IT WOULD STILL NOT STAY IN THE CONNECTOR BLOCK. THE PHYSICIAN USED ANOTHER TORQUE WRENCH BUT THE LEAD WOULD STILL NOT STAY. A NEW INS WAS THEN USED AND ¿IT WORKED¿. IT WAS NOTED THAT THE INSS WERE FROM THEIR TRUNK STOCK. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97118 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR