BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2965013 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02011
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 6, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCTS: C4TR01 IMPLANTABLE CRT-P, (B)(6) 2012; 4968-60 IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4). LEAD REMAINS IN USE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME INTO THE PHYSICIAN'S OFFICE COMPLAINING OF DIZZINESS. HIGH VENTRICULAR THRESHOLDS WERE NOTED, ALONG WITH NO CAPTURE ON BOTH RV (RIGHT VENTRICULAR) AND LV (LEFT VENTRICULAR) LEADS. THE RV LEAD WAS CAPPED AND REPLACED, AND THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67034 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR 5071-53 IMPLANTABLE PACING LEAD