BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 8000883 · Received October 24, 2018

    Report

    Report Number
    2182208-2018-01942
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    April 25, 2018
    Report Date
    October 24, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. POSSIBLE MODELS COULD INCLUDE THE SPRINT FIDELIS (6930, 6931, 6948, 6949). THE RECALL AND CORRECTION NUMBER LISTED ARE IN REFERENCE TO A PRODUCT FAMILY OF LEADS THAT ARE ASSOCIATED WITH THE FIELD ACTION. WITHOUT THE SPECIFIC MODEL NUMBER(S), IT IS NOT POSSIBLE TO ASSURE THE SPECIFIC PRODUCT CORRECTION NUMBER REFERENCED IN THE ARTICLE IS LISTED IN THIS REPORT. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE:TRANSVENOUS EXTRACTION OF ADVISORY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEADS WITH A RELATIVELY LONG IMPLANT DURATION. JOURNAL OF CARDIOLOGY. 2018; 72(4): 316-320. 10.1016/J.JJCC.2018.03.007. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE TACHY LEADS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS LEAD EXTRACTION DUE TO INFECTION, ELECTRICAL LEAD FAILURE WITH VENOUS OBSTRUCTION, OVERSENSING, AND INAPPROPRIATE SHOCKS DUE TO "LEAD FAILURE" IN MULTIPLE PATIENTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838769 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. MDT-FIDELIS-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R