BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3609421 · Received February 5, 2014

    Report

    Report Number
    3004209178-2014-01643
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Report Date
    January 15, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# V241707, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED, THE EVENT RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SHOCKING SENSATION IN THEIR BUTTOCKS AND GROIN. IT WAS STATED THE PATIENT HAD INTERMITTENT SHOCKING SENSATION IN THE BUTTOCK AND GROIN AND IT OCCASIONALLY RADIATED TO THEIR FOOT. THE PATIENT¿S DEVICE WAS INTERROGATED AND REPROGRAMMED ON (B)(6) 2013. IT WAS NOTED THE IMPEDANCE MEASUREMENTS WERE NORMAL. IT WAS LATER REPORTED THE PATIENT HAD SHOCKING DOWN THEIR LEG AND THEIR DEVICE WAS INTERROGATED AND REPROGRAMMED AGAIN ON (B)(6) 2014. IT WAS NOTED THE IMPEDANCE MEASUREMENTS WERE NORMAL STILL. REPORTEDLY, THE PATIENT¿S EVENT WAS ONGOING WITH NO FURTHER ACTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75206 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR