BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 3153561 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06098
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. PRODUCT: 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POOR SENSING ON THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE PACE/SENSE PORTION OF THE LEAD WAS REPLACED AND THE HIGH VOLTAGE PORTION 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
    258725 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R