BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3725149 · Received April 3, 2014

    Report

    Report Number
    3004209178-2014-05598
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    March 14, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 2000 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387-40, LOT# L82842, IMPLANTED: 2000 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V052560, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSSIBLY EARLY DEPLETION. IT WAS NOTED THAT THE PATIENT WAS NEVER GIVEN A PROGRAMMER AFTER SHE HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. IT WAS UNCLEAR IF THE PATIENT PROGRAMMER HAD BEEN LOST AND IT WAS NOTED THAT THE PATIENT HAD MOVED 2 TIMES SINCE IMPLANT. PATIENT HAD THE INS REPLACED ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT FELT SINCE SHE WAS NOT ABLE TO TURN THE INS OFF AT NIGHT THAT THE INS HAD DEPLETED EARLY. IT WAS FURTHER NOTED THAT THE HEALTHCARE PROFESSIONAL HAD NOT SAID THAT BUT HAD SAID THE INS HAD TO BE REPLACED. IT WAS NOTED THAT THE PATIENT HAD NOT RECEIVED A NEW PATIENT PROGRAMMER AT THE MOST RECENT REPLACEMENT BUT HAD BEEN ISSUED A PROGRAMMER AT AN EARLIER DATE. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202699 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention