BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE

    MDR report key: 2870151 · Received December 12, 2012

    Report

    Report Number
    2649622-2012-18273
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD GRADUALLY RISING CAPTURE THRESHOLDS OVER THE LAST 48 MONTHS. NO CHANGES HAVE BEEN MADE AND THE RA LEAD REMAINS 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
    1 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383059

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)