BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812103 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17151
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OVERLAY TUBING INSULATION WAS BREACHED FROM ENVIRONMENTAL STRESS CRACKING, BEING TORN AND CUT. THE OVERLAY TUBING INSULATION WAS OBSERVED TO HAVE BLOOD INGRESSION. THE INNER AND OUTER INSULATIONS WERE BREACHED FROM BEING CUT. THE OVERLAY TUBING INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE DISTAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED) AND WAS DISTORTED FROM BEING KINKED/BUCKLED. THE LEAD HAD APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THERE WAS NO INSULATION BREACH NOTED AT THE LEAD TRIFURCATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED DEVICE AND PROPHYLACTIC RIGHT VENTRICULAR [RV] LEAD CHANGE-OUT PROCEDURE, AN RV LEAD INSULATION BREACH WAS FOUND NEAR THE LEAD YOLK. THE RV 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 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD