BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3961487 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13592
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-41, LOT# VA042TZ, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER REPORTS NO STIMULATION SENSATION. THE CALLER REPORTS A LOSS OF THERAPEUTIC EFFECT. CALLER STATES THE INS (STIMULATOR) STOPPED WORKING THE NIGHT BEFORE REPORTED EVENT DATE AND HE HAD NO ONE TO CONTACT TO GET THE DEVICE CHECKED, DUE TO THE HOLIDAY WEEKEND. CALLER MENTIONS THE PATIENT DOES NOT HAVE AN APPOINTMENT BUT SHE WENT TO SEE THE HCP(HEALTHCARE PROVIDER) AND HCP WAS IN SURGERY AND NURSES DON¿T KNOW HOW TO READ THE INS. CALLER WAS SEEING A LOWER BATTERY INS ICON ON THE PATIENT PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437853 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR