BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3517757 · Received December 12, 2013

    Report

    Report Number
    3004209178-2013-23508
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Report Date
    August 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P940007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V260802, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE IN (B)(6) 2013 (A MONTH PRIOR TO REPLACEMENT, (B)(6) 2013) AND IT WAS DETERMINED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEAD AND THERE WAS A WIRE LOOSE. THE INS WAS SUBSEQUENTLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650725 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR