BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2792648 · Received October 16, 2012

    Report

    Report Number
    3004209178-2012-09224
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Report Date
    September 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387-40, LOT # J0546706V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID 3387-40 LOT# J0546706V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION ON THE EVENT, THE HEALTHCARE PROFESSIONAL (HCP) HAD REPORTED THAT THEY WERE NOT NOTIFIED OF ANY ISSUES WITH THIS PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A RETURN OF SYMPTOMS TODAY (ON THE CALL DAY): DYSKINESIA/QUIVERS. THE PATIENT NOTED HIS DEVICE WAS TURNED OFF AND WANTED ASSISTANCE TURNING IT BACK ON. THE PATIENT WAS ABLE TO TURN STIM BACK ON, ALSO CHECKED TO BE SURE THE OTHER IMPLANTABLE NEUROSTIMULATOR WAS ON. THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH THE PHYSICIAN OR MANUFACTURER'S REPRESENTATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT 3004209178-2012-09223

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF THE EVENT WAS THAT THE DEVICE HAD GOTTEN TURNED OFF ACCIDENTALLY WHEN CHECKED. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS UNCLEAR WHAT THE PATIENT OUTCOME WAS, AS IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY BUT ALSO NOTED THAT IT WAS A NON-SERIOUS INJURY/ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1