BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3111953 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07633
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 24, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V598061, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD SPONTANEOUSLY TURNED OFF PRIOR TO HER 24 MONTH VISIT. THE REPORTER INDICATED THAT THE PATIENT BELIEVED IT MAY HAVE BEEN RELATED TO GOING THROUGH A METAL DETECTOR AT THE "FRIENDS OF THE COURT." IT WAS NOTED THAT THE PATIENT EXPERIENCED AN UNDESIRABLE SENSATION OF SLIGHT BLADDER PRESSURE. IT WAS INDICATED THAT THE DEVICE WAS TURNED BACK ON (B)(6) 2013. ON (B)(6) 2013, THE DEVICE HAD AGAIN SPONTANEOUSLY TURNED ITSELF OFF AND THE PRESSURE HAD INCREASED. AN X-RAY WAS ALSO ORDERED ON THAT DAY AS PART OF THE 24 MONTH VISIT. THE REPORTER STATED THAT THE PATIENT WAS OFF ELMIRON. IT WAS NOTED THAT THE EVENT WAS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED BACK ON (B)(6) 2013. AS OF (B)(6) 2013 THERE NO FURTHER COMPLAINTS OF THE INS SPONTANEOUSLY TURNING OFF. THE PATIENT OUTCOME NOTED ON THE SAME DATE WAS REPORTED AS RESOLVED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212466 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1