BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1852267 · Received September 29, 2010

    Report

    Report Number
    3004209178-2010-07420
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT'S DEVICE WAS IMPLANTED ON (B)(6) 2010, IMPEDANCE READINGS WERE NORMAL. ON (B)(6) 2010, IMPEDANCE READINGS WERE GREATER THAN TEN THOUSAND. THE DEVICE WAS TESTED AT 1.5V AND 3.0V WITH IMPEDANCES "STILL SHOWING HIGH." THE PATIENT'S DEVICE WS REPROGRAMMED AND "HE DID GET SOME BENEFIT WITH REDUCTION IN STIFFNESS IN HIS CALF," BUT THE TESTING OF THE DEVICE SUGGESTED A POSSIBLE OPEN CIRCUIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN007448V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S, LOT# V479550| EXPLANTED:| LEAD: MODEL 3389S, LOT# V479550| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN007447V| IMPLANTED:| PROGRAMME: MODEL 37642, LOT# NJZ106621N| IMPLANTED:| IMPLANTED: