BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2634640 · Received June 29, 2012

    Report

    Report Number
    3004209178-2012-04948
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Report Date
    May 30, 2012
    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 64002, LOT# N230038, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V011138, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0555643V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S PHYSICIAN HAD RECOMMENDED THAT SHE UNDERGO A SURGICAL EVALUATION OF THE COMPONENTS OF THE DBS SYSTEM. THIS HAD NOT BEEN SCHEDULED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SWITCHING OFF. SEVERAL EPISODES WERE RECORDED IN (B)(6), 2012. IT WAS ALSO REPORTED THAT WHEN THE INS WAS SWITCHED ON, THE PATIENT RECEIVED A SHOCK. IT WAS UNKNOWN IF THE SHOCKING ONLY LASTED WHEN INITIALLY TURNED ON OR LONGER THAN THAT. THE PATIENT NOTICED THAT THE SYMPTOMS BEGAN AROUND THE TIME SHE HAD A CERVICAL SURGERY (DATE UNKNOWN). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DYSTONIA SYMPTOMS SEEMED TO BE GETTING WORSE AFTER A NECK SURGERY (B)(6) 2012. THE INS WAS CHECKED AND WAS FOUND TO BE TURNED OFF. WHEN THE DEVICE WAS TURNED ON, THE PATIENT EXPERIENCED A "SHOCKING" SENSATION. THE PATIENT'S HUSBAND ATTEMPTED TO TURN THE DEVICE ON AFTER THAT INCIDENT WITH THE SAME RESULTS. THE "SHOCKING" WAS INTOLERABLE TO HER SO THEY HAVE NOT "BEEQUIT" USING THE STIMULATOR WHICH CAUSED HER DYSTONIA SYMPTOMS TO WORSEN. FURTHER TROUBLESHOOTING WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention