BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2402469 · Received January 6, 2012

    Report

    Report Number
    3004209178-2012-00117
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 17, 2011
    Report Date
    December 18, 2011
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3389S-40 LOT #V801522 IMPLANTED: (B)(6) 2012; LEAD MODEL 3389S-40 LOT #V801522 IMPLANTED: (B)(6) 2012; EXTENSION MODEL 37085-60 (B)(4) IMPLANTED: (B)(6) 2012; EXTENSION MODEL 37085-60 (B)(4) IMPLANTED: (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL WHERE HE HIT THE BACK OF HIS THE HEAD. THE SYSTEM WAS REPORTED TO BE ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. THE REPORTER STATED EVERYTHING WAS "OKAY" WITH THE PATIENT AND THE DEVICE. ALL ISSUES WERE RESOLVED.

    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 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR