BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2954733 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02409
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    October 25, 2012
    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. PRODUCT: 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005; 5076 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD POSSIBLE PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD AND THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE. THE ICD WAS EXPLANTED AND REPLACED AND THE LV AND THE RA 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
    58893 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419388

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR