BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2203152 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11826
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE DEFIBRILLATION COIL WAS DISTORTED, SEVERAL CONDUCTORS DISTORTED, THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER TUBING WAS KINKED/BUCKLED, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK, THE OUTER TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACK BREACH (NON ELECTRICAL), THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE LEAD WAS FLEXED, WITHIN FIVE CENTIMETERS OF THE ANCHORING SLEEVE AND THE LEAD WAS STRETCHED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED, THE DEFIBRILLATION COIL WAS DISTORTED, SEVERAL CONDUCTORS DISTORTED, THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER TUBING WAS KINKED/BUCKLED, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK, THE OUTER TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACK BREACH (NON ELECTRICAL), THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE LEAD WAS FLEXED, WITHIN FIVE CENTIMETERS OF THE ANCHORING SLEEVE AND THE LEAD WAS STRETCHED. 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

    INFECTION AND EROSION OF THE DEVICE WERE REPORTED. THE SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. EROSION/NECROSIS.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTION. THE LEAD WAS REMOVED, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO FURTHER 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD