BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1049779 · Received May 8, 2008

    Report

    Report Number
    2649622-2008-02083
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4). EVALUATION SUMMARY: (B)(4) DETAILED ANALYSIS OF THE LEAD WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS ALMOST PULLED OUT OF THE DEVICE, DUE TO TWIDDLER'S SYNDROME. THE LEAD WAS CUT, CAPPED, AND REPLACED BECAUSE OF SHORT V-V INTERVALS, INDICATING OVERSENSING, AND NOISE. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED FROM AN ATTORNEY ALLEGING THE "PLAINTIFFS HAVE SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES" ASSOCIATED WITH ONE OR MORE OF THE FOLLOWING: "THE IMPLANTATION, RECALL, FAILURE, REMOVAL/REPLACEMENT, AND/OR INABILITY TO HAVE THE DEFECTIVE [LEAD] REMOVED OR REPLACED." THE PATIENT REPORTED THEY MAY HAVE A SURGERY SCHEDULED TO "FIX DEVICE." THEY STATED THAT "LEAD CAN SHOCK STOMACH AND DEVICE FLOPS IN CHEST." NO FURTHER PATIENT COMPLICATIONS WERE 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD