BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3070848 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06641
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 1, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# VA02DME, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN GOING THROUGH THE SECURITY GATES THE INS WAS TURNING OFF. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE THERAPY BUT WAS WORKING WITH THEIR PHYSICIAN TO RESOLVE THE ISSUE THE ISSUE. APPOINTMENTS OF (B)(6) 2013 WERE NOTED. FURTHER FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) ON THE SAME DAY REPORTED THAT THE CAUSE OF THE EVENT WERE "SECURITY GATES". REPROGRAMMING WAS PERFORMED ON (B)(6) 2013. PATIENT SYMPTOMS OF A ¿RETURN OF SYMPTOMS¿ WERE REPORTED. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173134 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1