BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2802749 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09460
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 28, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-33 LOT# V871805, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3093-33 LOT# V786385, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT "FIGURE THE DEVICE OUT," AND THE DEVICE "HASN'T WORKED BASICALLY SINCE IMPLANT." ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN OUT OF TOWN FOR THE SUMMER. THE PATIENT WAS SUPPOSED TO MEET A MANUFACTURER REPRESENTATIVE, BUT CANCELLED STATING THAT THINGS HAD RESOLVED AND GOTTEN BETTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1