BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151720 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05643
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MEDICAL PRODUCTS: 694965, IMPLANTABLE TACHY LEAD, (B)(6) 2005; 507652, IMPLANTABLE PACING LEAD, (B)(6) 2005; D334TRG, IMPLANTABLE PACEMAKER/CARDIO/DEFIB, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORT THAT THE LEFT VENTRICULAR (LV) LEAD¿S INSULATION WAS DAMAGED DURING A LEAD REVISION. THE LV LEAD WAS REPAIRED 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
    252413 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R