BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 1854946 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09205
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) OUTER INSULATION BREACHED; FULL LEAD RETURNED AND ANALYZED. THE LEAD WAS RECEIVED WITH A LARGE AMOUNT OF FOREIGN MATTER (POSSIBLY TISSUE) ON THE HELIX. THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION WAS MELTED, THE INNER INSULATION WAS TORN, AND THE LEAD WAS STRETCHED. BLOOD/BODY FLUID WAS PRESENT ON THE PROXIMAL CONDUCTOR AND IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD UNACCEPTABLE THRESHOLDS, NO CAPTURE, UNDERSENSING, AND IT HAD DISLODGED. FLOUROSCOPY SHOWED THAT THE DISTAL END OF THE LEAD WAS POINTING DOWN TOWARD THE INFERIOR VENA CAVA. THE LEAD WAS EXPLANTED 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 19 YR Required Intervention 4068 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PULSE GENERATOR