BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2965175 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01860
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 31, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT CONTINUED: (B)(4), (B)(6) 2012. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED THREE DAYS AFTER IMPLANTATION. THE PATIENT WAS BROUGHT INTO THE HOSPITAL AND WAS STABLE. THE NEXT DAY THE LEAD WAS REPOSITIONED; HOWEVER, DURING THE PROCEDURE, THE PATIENT WENT INTO HEART BLOCK. THE PHYSICIAN REQUESTED THAT A TEMPORARY PACING LEAD BE IMPLANTED TO PROVIDE BACK-UP PACING. ONCE THE REPOSITIONED RV LEAD WAS IN PLACE, THE TEMPORARY LEAD WAS EXPLANTED. THE REPOSITIONING WAS SUCCESSFUL, REMAINS IN USE, AND THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68729 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| L| R RVDR01 IMPLANTABLE PULSE GENERATOR