BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3091498 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07233
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 26, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # VA00Q5R, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWICE OVER THE TIME THE PATIENT HAD THE IMPLANT, HE HAD TURNED THE DEVICE OFF AND THEN BACK ON AFTER "ABOUT A WEEK" AND FELT A "JOLT." THE PATIENT HAD TURNED HIS DEVICE OFF TO COMPARE SYMPTOMS WITH AND WITHOUT THE DEVICE. THE PATIENT STATED HE WAS "NOT REPORTING A DEFECT," JUST TALKING ABOUT WHAT HAPPENED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT TURNED THE STIMULATION BACK ON IT "VIBRATED LIKE THE DEVIL" AND THEY TURNED IT DOWN AND IT EVENTUALLY WENT AWAY. THE PATIENT'S NERVES AND MUSCLES "FLEXED" IN RESPONSE AND THE PATIENT THOUGHT THEY SHOULD TURN IT OFF AGAIN BUT WAITED A LITTLE BIT AND IT KIND OF EASED UP AND WENT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193577 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1