BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2854994 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11090
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 28, 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
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 64001, LOT # N293019, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 64001, LOT # N293019, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # V251538, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V297034, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS EXPERIENCING "SOME SPEECH FREEZING," TEN SECONDS IN LENGTH ABOUT SIX TIMES A DAY. WHEN CONTACT THREE WAS "OUT OF THE MIX", THE PATIENT GOT NECK AND JAW TIGHTENING "RIGHT AWAY." ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 REPORTED THAT THE PATIENT HAD "GREAT BENEFIT," BUT WAS GETTING THE EPISODES IN WHICH HE COULD NOT SPEAK OR SWALLOW. IF THE PATIENT WAS EATING AT THE TIME HE HAD TO SPIT OUT HIS FOOD OR RISK NOT BEING ABLE TO SWALLOW AND CHOKE. REPROGRAMMING HAD BEEN DONE WITHOUT SUCCESS AND "PALPATION DID NOT REPRODUCE." THERE WAS ALSO A "VERY SMALL, SUSPICIOUS KINK" ON AN X-RAY, ONE "FINGER BREADTH" ABOVE THE LEAD AND EXTENSION CONNECTION. THE LEAD AND EXTENSION WERE THOUGHT TO BE "CHRONIC" AND IT WAS TO BE DETERMINED IF THE ADAPTOR, DEVICE, AND EXTENSION SHOULD BE REMOVED. ADDITIONAL INFORMATION WAS 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 MDT PUERTO RICO OPERATIONS CO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1