BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3153129 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05816
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. PRODUCT ID (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2013; (B)(4) IMPLANTABLE PULSE GENERATOR (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL HOURS AFTER A RIGHT VENTRICULAR (RV) LEAD REPLACEMENT PROCEDURE, LOSS OF CAPTURE WAS NOTED. THE RV LEAD WAS NOTED TO HAVE BEEN PROGRAMMED TO HIGH OUTPUT AT THE END OF THE PROCEDURE. THE PHYSICIAN DID ANOTHER REVISION PROCEDURE TO CHECK THE LEAD POSITION AS X-RAY SHOWED THE ATRIAL LEAD WAS PULLED BACK. SLACK WAS ADDED TO BOTH THE ATRIAL AND VENTRICULAR LEAD. BOTH LEADS REMAIN 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
    255999 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R