BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2635098 · Received June 29, 2012

    Report

    Report Number
    3004209178-2012-04981
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Report Date
    June 1, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 64002, LOT# N319253, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: POCKET ADAPTER; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3387S-40, LOT# V015069, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V021705, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND COULD NOT ADJUST STIMULATION. ACCORDING TO THE PATIENT'S SON, THE PATIENT WAS "ALMOST COMATOSE" AND HAD TREMORS; THE PATIENT'S SON NOTED THAT THAT WAS HOW THE PATIENT WAS WHEN THE THERAPY WAS NOT ON. THE IMPLANTABLE NEUROSTIMULATOR (INS) NEEDED TO BE CHARGED. THE PATIENT'S SON WAS GOING TO CHARGE THE INS AND CONTACT THE PATIENT'S PHYSICIAN IF THAT DID NOT RELIEVE THE PATIENT'S SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PHYSICIAN RECENTLY SAW THE PATIENT IN (B)(6), AND THE ISSUE WAS THAT THE PATIENT WAS FALLING ASLEEP DURING RECHARGING SESSIONS. IN THAT SCENARIO, THE PHYSICIAN FELT THAT THE PATIENT WAS LOSING COUPLING AS THE ANTENNA WOULD SLIDE AWAY FROM THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PHYSICIAN RE-EDUCATED THE PATIENT ON PROPER RECHARGING METHODS, AND IT WAS REPORTED THAT THE PHYSICIAN WOULD CONTINUE TO FOLLOW THE PATIENT'S PROGRESS. THE PHYSICIAN STATED THAT THERE IS NO "HARDWARE ISSUE" AND THAT THE PATIENT COULD RECHARGE NORMALLY.

    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 37612

    Patients

    Seq Age Sex Outcome Treatment
    1