BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2964382 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01889
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY THAT FOUR HOURS AFTER BEING DISCHARGED FROM AN IMPLANT, THE PATIENT SUFFERED A PERFORATION OF THE HEART. THE PATIENT WAS BLEEDING INTERNALLY AND HOSPITALIZED. FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON THE PATIENT AND TO INDICATE IF THIS INCIDENT WAS RELATED TO THE RIGHT ATRIAL (RA) LEAD OR RIGHT VENTRICULAR (RV) LEAD, ALONG WITH WHAT INTERVENTIONS MAY HAVE BEEN PERFORMED, BUT THE ATTEMPTS WERE UNSUCCESSFUL. RECORDS INDICATE THE LEADS REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68213 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| L (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)