BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 2954514 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02287
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CALLED TO REPORT THAT SINCE THEIR IMPLANT THEY HAVE EXPERIENCES A THUMPING BELOW THEIR LEFT BREAST AND INTO THEIR CHEST AREA AT NIGHT WHEN LYING ON THEIR LEFT SIDE. FOLLOW-UP WAS CONDUCTED AND THE INFORMATION OBTAINED FROM FOLLOW UP STATED THAT SINCE IMPLANT THE PATIENT HAS BEEN SEEN MULTIPLE TIMES, AND THERE HAS BEEN SOME REPROGRAMMING DONE TO PROGRAM AROUND DIAPHRAGMATIC STIMULATION. THE SYSTEM IS NOW WORKING FINE AND EVERYTHING IS NORMAL. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED FROM FOLLOW-UP INFORMATION THAT ONLY THE LV (LEFT VENTRICULAR) LEAD WAS REPROGRAMMED. THE RV (RIGHT VENTRICULAR LEAD'S PROGRAMMING REMAINED THE SAME. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58716 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB