BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3051196 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04826
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    December 30, 2009
    Report Date
    December 6, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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). CONCOMITANT MEDICAL PRODUCTS: 6943, IMPLANTABLE TACHY LEAD, (B)(6) 2001; 5568, IMPLANTABLE PACING LEAD, (B)(6) 2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. IT WAS NOTED THAT THE SUTURES HAD BECOME LOOSE AND THE LEAD HAD NO SLACK AND WAS IN THE RIGHT ATRIUM. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE SYSTEM LONGEVITY STUDY. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD ALSO HAD HIGH THRESHOLDS. IT WAS NOTED THAT THE SUTURES HAD BECOME LOOSE AND THE LEAD HAD NO SLACK AND WAS PULLED BACK. THE LV LEAD WAS REPOSITIONED AND REMAINS 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
    149147 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR