BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3243336 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12190
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA053X3, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT TURNED STIMULATION ON A COUPLE WEEKS PRIOR TO REPORT, SHE COULD FEEL ¿A LITTLE STIMULATION BUT NOT LIKE SHE NORMALLY DID.¿ THE PATIENT STATED THE DOCTOR THOUGHT THERE WAS ¿SOMETHING WRONG WITH THE DEVICE SOME PLACE.¿ (B)(4) IT WAS STATED THE DIFFERENT SETTINGS WERE BEING TESTED TO GET THE MOST RELIEF. REPORTEDLY THE ISSUE WAS RELIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343270 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR