BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3032521 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04522
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA05V2K, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SAW THE "CALL YOUR DOCTOR" ICON ON THEIR PROGRAMMER, AS WELL AS A POWER-ON-RESET (POR) CONDITION. IT WAS STATED THAT THE PATIENT WAS IMPLANTED THE PREVIOUS DAY AND THE HEALTH CARE PROVIDER HAD NOT PROGRAMMED OR TURNED THE STIMULATOR ON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE EVENT WAS UNABLE ADJUSTING STIMULATION. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137425 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR