BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2791131 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14498
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    May 14, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT DURING AN ELECTIVE LEAD EXTRACTION PROCEDURE THE PATIENT DEVELOPED A HEMOTHORAX. FOLLOW-UP WAS CONDUCTED WITH THE PHYSICIAN WHO STATED THE CAUSE OF THE COMPLICATIONS WAS THE EXTRACTION PROCEDURE. THE PATIENT REPORTED REQUIRING A CHEST TUBE, SPENDING 4 DAYS IN ICU, AND "NEARLY 3 MONTHS OF RECOVERY TIME". CHEST PAIN, TROUBLE BREATHING, WEAKNESS AND LACK OF STAMINA WERE ALSO NOTED. THE LEAD WAS EXTRACTED AND REPLACED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R 4076 IMPLANTABLE PACING LEAD| D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB