BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3971109 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13762
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA05BDP, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GOING TO HAVE CATARACTS SURGERY USING AN ULTRASOUND TO BREAK UP THE EXISTING CATARACTS. THEY WERE UNSURE IF THE ULTRASOUND WAS DIAGNOSTIC OR THERAPEUTIC. THE PATIENT INQUIRED IF THEY COULD HAVE CATARACTS SURGERY. IT WAS NOTED THEY HAD INCORRECT PROGRAMMING A YEAR AND A HALF PRIOR TO REPORT. AT THE FIRST IMPLANT SURGERY THE WIRES WERE CROSSED AND THEY PROGRAMMED THE PATIENT INCORRECTLY. IT WAS NOTED AN MRI WAS PERFORMED AND BOTH OF THE PROBES WERE OFF. THE PATIENT HAD LOTS OF TROUBLE AND "NOTHING WORKED." A REVISION SURGERY WAS PERFORMED TWO WEEKS PRIOR TO REPORT. THEY HAD ONE PROBE CORRECTED AND THE MRI SHOWED IT WAS CORRECTLY POSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447731 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention