BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3051846 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04921
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 3, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2013.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 DAYS POST IMPLANT, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN. IT WAS NOTED THAT POST DISCHARGE THE PATIENT HAD GONE HOME AND CHOPPED WOOD. THERE WAS FLUID AROUND THE HEART AND AN RV LEAD PERFORATION WAS SUSPECTED BUT AN X-RAY COULD NOT CONFIRM THAT. THE FLUID WAS REMOVED AND THE LEAD WAS REPOSITIONED. THE LEAD 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
    152167 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| L| R SEDR01 IMPLANTABLE PULSE GENERATOR (IPG)