BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3153534 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06089
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PRODUCTS 5076 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    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 ONE DAY AFTER IMPLANT THE PATIENT EXPERIENCED BRADY-TACHY SYNDROME AND IT WAS FOUND THAT THE RIGHT VENTRICULAR(RV) LEAD WAS DISLODGED. THE PHYSICIAN ELECTED TO REMOVE THE LEAD AND REPLACE IT WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258139 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)