BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4252019 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21635
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387-40, LOT# V002332, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# V002332, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR HEALTHCARE PROFESSIONAL (HCP) OR A MANUFACTURING REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON 2014 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPRESSED DISSATISFACTION WITH THE LONGEVITY. THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD DEPLETED IN (B)(6) 2014 AND THE PATIENT HAD SEEN END OF SERVICE (EOS) ON THE PATIENT PROGRAMMER. THE DEVICE WAS REPLACED ON (B)(6) 2014. THE PATIENT¿S BATTERY WAS REPLACED BECAUSE THE BATTERY DIED; IT WAS UNCLEAR IF IT WAS NORMAL BATTERY DEPLETION. TO THE PATIENT LONGEVITY HAD SEEMED TOO SHORT FROM WHAT HE HAD BEEN TOLD INITIALLY. THE PATIENT HAD DYSTONIA AND HAD TO WAIT 6-8 WEEKS IF HE NEEDED A BATTERY REPLACEMENT. NO OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736534 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention