BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3087791 · Received May 1, 2013

    Report

    Report Number
    3004209178-2013-07146
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 15, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 093-28, LOT# V013722, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF. ADDITIONALLY, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE PATIENT'S SYMPTOMS RETURNED A COUPLE OF MONTHS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT WASN'T USING HIS PROGRAMMER AND "KEPT IT IN THE BOX". THERE WAS NO TELEMETRY POSSIBLE AT THE TIME OF THE REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189836 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1