BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 5268667 · Received December 4, 2015

    Report

    Report Number
    2182208-2015-03881
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    January 1, 2015
    Report Date
    November 12, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: VALUE OF A JOINT CARDIAC SURGERY - CARDIAC ELECTROPHYSIOLOGY APPROACH TO LEAD EXTRACTION. JOURNAL OF CARDIAC SURGERY,. 2015;30(11):874-876. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT'S IMPLANTABLE TACHY LEAD. THE ARTICLE INDICATED THAT 18 MONTHS AFTER THE INITIAL IMPLANTATION OF THE LEAD, THE PATIENT UNDERWENT LEAD EXTRACTION DUE TO AN APPARENT LEAD FRACTURE. DURING THE PROCEDURE, THE LASER SHEATH COULD NOT BE ADVANCED. THERE WAS NOTED PERICARDIAL EFFUSION AND A LACERATION WAS IDENTIFIED. THIS WAS REPAIRED AND THE PATIENT RECOVERED WELL AND WAS DISCHARGED AFTER FIVE DAYS. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797005 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Hospitalization| L| R