BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3154896 · Received June 8, 2013

    Report

    Report Number
    3007566237-2013-01890
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, IT WAS NOTED THIS WAS A DYSTONIA PATIENT. UPDATED PMA # TO H020007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIDN¿T HAVE GOOD DYSTONIC CONTROL ON THE LEFT SIDE OF THE BODY. IMPEDANCES WERE ¿JUMPING AROUND¿. FOR CONTACT 0/1, IMPEDANCES JUMPED FROM 1700 OHMS TO 504 OHMS. OTHER IMPEDANCES RANGED BETWEEN 2023 OHMS TO 3580. AN XRAY WAS ADVISED, AS A POSSIBLE CONNECTION ISSUE WAS MENTIONED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    SEVERAL FOLLOW UP ATTEMPTS TO THE HEALTHCARE PROFESSIONAL (HCP WERE UNSUCCESSFUL AND NO ADDITIONAL INFORMATION WAS OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254421 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37602

    Patients

    Seq Age Sex Outcome Treatment
    1