BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3192988 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10963
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40 LOT# V100240; PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V100240, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37602 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37651 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 64001 LOT# N286713, IMPLANTED: 2011 (B)(6); PRODUCT TYPE ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ¿GOT REALLY MESSED¿ BECAUSE, SHE WAS PROGRAMMED WRONG, AND SHE HAD TO GO TO A DIFFERENT HCP IN (B)(6) TO FIX IT. THE PATIENT DID NOT TRUST ANYBODY TO PROGRAM HER DEVICE EXCEPT THOSE TAKING INFORMATION FROM HER DOCTOR AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292553 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR