BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2326854 · Received November 7, 2011

    Report

    Report Number
    3004209178-2011-09078
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Report Date
    November 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    PROGRAMMER: MODEL 3037, SERIAL# (B)(4). LEAD: MODEL 3889-28, LOT# V011665, IMPLANTED: 2006 (B)(6), EXPLANTED: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNING OFF. THE PATIENT HAD LOST THE PROGRAMMER, AND KEPT COMING BACK TO THE CLINIC WITH THE INS TURNED OFF. THE CALLER WAS SHOWN HOW TO TURN OFF THE MAGNETIC REED SWITCH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THE PATIENT'S DEVICE HAD A MAGNETIC SWITCH IN IT THAT CAN CAUSE THE DEVICE TO TURN ON/OFF IF IT COMES IN CONTACT WITH A MAGNET. THIS SWITCH WAS TURNED OFF BY THE PATIENT'S HEALTH CARE PROVIDER. THE PATIENT STILL DID NOT HAVE A PATIENT PROGRAMMER, AND WAS INSTRUCTED ON HOW TO OBTAIN A NEW PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 3889-28 LOT# V011665 IMPLANTED: UNK EX