BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3051463 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04880
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. (B)(4): C4TR01 IMPLANTABLE PULSE GENERATOR 2012-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN THREE WEEKS OF IMPLANT, THE LEFT VENTRICULAR LEAD WAS NO LONGER CAPTURING AND THE LEAD WAS THOUGHT TO BE DISLODGED. THE DISLODGEMENT WAS CONFIRMED BY X-RAY. THE PHYSICIAN OPTED TO PROGRAM THE LEAD OFF. THE LEAD REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153734 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention 4194 IMPLANTABLE PACING LEAD