BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1013471 · Received March 10, 2008

    Report

    Report Number
    2649622-2008-00882
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 5, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT REPORTED THAT THE RV LEAD WAS EXPLANTED DUE TO VARYING HIGH LEAD IMPEDANCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ATTORNEY ALLEGES THE PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, AND SEVERE EMOTIONAL DISTRESS AS A RESULT OF THE LEAD. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS OPERATIONAL CONTEXT CONTRIBUTED TO EVENT IMPEDANCE, HIGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD WAS EXPLANTED DUE TO VARYING HIGH LEAD IMPEDANCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ATTORNEY ALLEGES THE PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, AND SEVERE EMOTIONAL DISTRESS AS A RESULT OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB