BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1050031 · Received May 8, 2008

    Report

    Report Number
    2649622-2008-02593
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: IT WAS REPORTED THE LEAD WAS EXPLANTED DUE TO FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S ATTORNEY ALLEGES THE PATIENT HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND SEVERE EMOTIONAL DISTRESS. NO CONCLUSION CAN BE DRAWN. LEAD(S), FRACTURE OF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS EXPLANTED DUE TO FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S ATTORNEY ALLEGES THE PATIENT HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND SEVERE EMOTIONAL DISTRESS.

    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 71 YR Other| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD