BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4190609 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20119
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    September 29, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-33, LOT # V020254, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2010 THE WIRES WERE LOOSE SO THE PATIENT¿S DEVICE WAS REPROGRAMMED AND AMPED UP. THE PATIENT PEED A LOT. SHE HAD TO DO SOME EXERCISES FOR A BACK INJURY AND IT SEEMED LIKE THE DIMINISHMENT WAS RELATED TO THAT AND THAT AREA WAS DISRUPTED. THE DOCTOR¿S OFFICE SAID IT APPEARED THAT MAYBE THE WIRES WEREN¿T WORKING SO THEY AMPED UP THE VOLTAGE SO SHE COULD FEEL IT, WHICH SEEMED TO HELP. A HEALTHCARE PROFESSIONAL LATER REPORTED THAT THERE WAS NO ISSUE WITH LOOSE WIRES IN 2010 AND THE PATIENT WASN¿T HAVING ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667283 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR