BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 3991439 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08117
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 VEDR01 IPG IMPLANTED: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT EXPERIENCED LIGHT HEADEDNESS DUE TO NO CAPTURE ON THE RV LEAD. IT WAS NOTED THAT THE THRESHOLDS INCREASED AND WAS HIGH. THE LEAD WAS REVISED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469094 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 5076-52 LEAD