BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3475354 · Received November 18, 2013

    Report

    Report Number
    3004209178-2013-21005
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Report Date
    November 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28, LOT# V181439, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT, THE INTERSTIM HAD NOT BEEN WORKING. IT WAS STATED THAT ¿IT WAS NOT WORKING, BUT WAS NOT HURTING.¿ THE PATIENT INDICATED THE BATTERY ¿MAY NEED TO BE REPLACED.¿ A PRODUCT MALFUNCTION WAS NOT CONFIRMED. THE PATIENT HAD AN APPOINTMENT ABOUT A YEAR PRIOR BECAUSE THEIR DEVICE WAS NOT WORKING. THE HEALTHCARE PROVIDER NOTED, THE PATIENT WAS ABLE TO URINATE AND VOID COMPLETELY, BUT THE PATIENT WAS UNSURE IF THE INTERSTIM WAS THE CAUSE. IT WAS STATED, THE MANUFACTURER REPRESENTATIVE WAS AT THE APPOINTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597659 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male