BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2673507 · Received July 30, 2012

    Report

    Report Number
    3004209178-2012-06198
    Event Type
    Malfunction
    Date Received
    July 30, 2012
    Report Date
    June 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V890309, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A FALL ON (B)(6) 2012. THE PATIENT FELL NEAR A SIDEWALK AND POOL AND INJURED HER KNEE. THE PATIENT HAD ALSO BEEN IN THE PROCESS OF MOVING AND HAD BEEN PERFORMING HEAVY LIFTING ON (B)(6) 2012. IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT INCREASED AMPLITUDE TO 2.8 V. THE PATIENT INCREASED AMPLITUDE BY 0.1 V MULTIPLE DAYS OVER THE NEXT WEEK OR SO TO AN AMPLITUDE OF 3.3 V. THE PATIENT WAS GOING TO CONTINUE TO MONITOR SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1