BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 2050805 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05434
    Event Type
    Injury
    Date Received
    April 12, 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
    TN, 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: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS NOTED THAT THE INSULATION WAS PULLED OVER THE TIP ELECTRODE, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE DISTAL CONDUCTOR FRACTURED DUE TO OVERSTRESS, THE PROXIMAL CONDUCTOR FRACTURED DUE TO OVERSTRESS, THE INNER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PECTORAL MUSCLE STIMULATION, AND THERE WAS A FRACTURE AND A BREACH IN THE INSULATION OF THE RIGHT ATRIAL LEAD. THE LEAD WAS REMOVED AND REPLACED. THE RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE 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 62 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR