BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2061795 · Received March 30, 2011

    Report

    Report Number
    3004209178-2011-02421
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    October 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. ALL IMPEDANCES WERE WITHIN NORMAL LIMITS WHEN MEASURED ON (B)(4) 2011. NO SURGICAL INTERVENTION HAD OCCURRED, THOUGH IT WAS POSSIBLE THAT THE HCP WOULD REMOVE THE INTERSTIM OR PLACE IT DEEPER INTO THE TISSUE. THE PATIENT DIDN'T WANT TO USE THE DEVICE DUE TO THE POSSIBILITY OF A REPEAT SHOCKING EXPERIENCE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION WHICH WAS EXPERIENCED DURING LIGHTNING STORMS WITH THE DEVICE TURNED ON OR OFF. THE EVENT OCCURRED LAST SATURDAY/SUNDAY AND LAST EVENING WHEN IT WAS STORMING. THE GROUNDING IN THE PT'S HOME WAS OKAY. THE PT ALSO EXPERIENCED EXPOSURE TO A THEFT DETECTOR OR SECURITY GATE AT LOWES WHEN THE DEVICE WAS TURNED ON. ADDITIONAL INFO WAS REQUESTED.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR IMPLANTED:| LEAD: MODEL 3889, LOT # V612849| EXPLANTED: