BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2182206 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05199
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LOW IMPEDANCES WERE REPORTED. IMPEDANCE ON THE 0-1 COMBINATION WAS 31 OHMS. IMPEDANCE FOR THE THERAPY MEASURED 1,094 OHMS. THE BATTERY VOLTAGE WAS 2.64 VOLTS. ADD'L INFO HAS BEEN 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 PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR EXPLANTED:| EXTENSION: MODEL 7482, LOT# NGK015248N| EXTENSION: MODEL 7482, LOT# NHU091602V| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0519515V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0217111V| IMPLANTED: