BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 2203414 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11868
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY FOR (B)(4): CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. THIS DEVICE IS PART OF THE FIELD ACTION AND HAS TESTED CONSISTENT WITH THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN APPARENT FRACTURE. ALSO THE DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT SECURE IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 3830 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 4592 IMPLANTABLE PACING LEAD