BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3329980 · Received September 6, 2013

    Report

    Report Number
    3004209178-2013-15780
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    August 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V813549, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS ABLE TO CONNECT WITH THE PATIENT AND DISCUSSED HER CURRENT NEED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. THE PATIENT WAS REFERRED TO A SURGEON THAT TAKES MEDICAID AND THE PATIENT WAS SCHEDULED FOR A CONSULT.

    Description of Event or Problem · 1

    IT WAS STATED THE PATIENT¿S BLADDER WAS SO MESSED UP THAT SHE HAD REGULAR SURGERIES ON IT AND THERE WAS NO MORE PROTECTIVE LINING LEFT OF HER BLADDER. REPORTEDLY THE PATIENT WAS CONCERNED SHE WILL BE PERMANENTLY INJURED FOR LIFE IF THIS DEVICE IS NOT EXPLANTED SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444406 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention