BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2931845 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00300
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT # V388241, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V388241, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGHER THAN NORMAL IMPEDANCES POST-OPERATION, BUT IT MIGHT HAVE BEEN DUE TO EDEMA AND A POST-PROCEDURE INFECTION. THE PHYSICIAN DID NOT WANT TO REMOVE THE LEAD SO THEY WATCHED SYMPTOMS AND EVERYTHING RESOLVED ITSELF. THE INITIAL IMPLANT WAS MORE THAN 2 YEARS AGO. IT WAS STATED THAT THERE WAS POSSIBLE SCARRING IN THE TRACK THAT MAY BE THE CAUSE OF THE HIGHER IMPEDANCES. IT WAS STATED THAT THE VOLTAGE HAD BEEN "SLOWLY" CREEPING UP OVER TIME, BUT THE IMPEDANCES HAVE REMAINED STABLE. THE PATIENT WAS RECEIVING "GOOD" THERAPY BENEFIT CURRENTLY. NO FURTHER INFORMATION ABOUT THIS EVENT WAS PROVIDED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38099 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other