BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3892407 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11990
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3389S-40, LOT# V991333, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# VA00WUZ, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEMS ON BOTH SIDES OF THE PATIENT WERE REMOVED. THE PATIENT REQUESTED THE REMOVAL DUE TO A LACK OF BENEFIT AND ANXIETY FROM THE DEVICE IN HER BODY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURING REPORT #3004209178-2014-01453 AS THE PATIENT¿S OTHER INS HAD IMPEDANCES ISSUES AND WAS ALSO REMOVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SURGEON PROVIDED VERY LITTLE DETAILS TO THE REPORTER. THERE WAS NO MALFUNCTION AND THE REPORTER WAS TOLD THE "PROTEST" DID RECEIVE BENEFIT FROM STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367604 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention