BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA SC

    MDR report key: 2061843 · Received April 4, 2011

    Report

    Report Number
    3004209178-2011-02567
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCE READINGS WERE SEEN DURING AN IMPLANT PROCEDURE. IT WAS STATED ELECTRODE COMBOS 0-1, 1-3, AND 0-3 WERE SHOWING READINGS OF <10 OHMS. THESE COMBOS WERE NOT USED IN PROGRAMMING. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA SC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0225583V| EXTENSION: MODEL 7482A51, LOT# NHU140238V| IMPLANTED: