BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 3153448 · Received June 8, 2013

    Report

    Report Number
    3008973940-2013-00068
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4): A3DR01 IMPLANTABLE PULSE GENERATOR 2013-(B)(6), 5086MRI52 IMPLANTABLE PACING LEAD 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE PATIENT COMPLAINED OF CHEST PAIN. "PACING FAILURE" WAS OBSERVED. THE NEXT DAY, A HEMOTHORAX IN THE LEFT LUNG WAS CONFIRMED AS THE VENTRICULAR LEAD HAD PERFORATED THE ANTERIOR WALL AROUND THE APEX. AFTER OBTAINING HEMOSTASIS, THE LEAD WAS REPOSITIONED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THISEVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259004 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC SINGAPORE OPERATIONS 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| L| R