BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3800766 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08759
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V014191, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3387S-40, LOT# V014191, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37085-60, LOT# SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO HURT THEMSELVES. THERE WAS NO ALLEGED PRODUCT ISSUE. THERE WERE NO ACTIONS REQUIRED AS A RESULT OF THE EVENT. THE PATIENT WAS ALIVE WITH INJURY. THE PATIENT CUT THEIR WRIST IN AN ATTEMPT TO HURT HIMSELF AND WAS HOSPITALIZED. THE PATIENT HAD LACERATIONS TO WRISTS AND EXISTING MENTAL HEALTH ISSUES. IT WAS NOTED THAT THIS WAS NOT DEVICE RELATED; THE PATIENT HAD INJURIES TO THE WRISTS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HOME WITH HIS FAMILY. THE DEEP BRAIN STIMULATOR THERAPY WAS UNAFFECTED AND CONTINUED TO WORK EFFECTIVELY. THE PATIENT WAS UNDER PSYCHIATRIC CARE TO MANAGE HIS DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279246 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| L