BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 5862904 · Received August 9, 2016

    Report

    Report Number
    2182208-2016-02100
    Event Type
    Injury
    Date Received
    August 9, 2016
    Date of Event
    April 1, 2016
    Report Date
    May 6, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP INFORMATION OBTAINED FROM THE AUTHOR/PHYSICIAN. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/MANUFACTURER SERIAL NUMBERS. 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. 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: CONSIDERATIONS FOR CARDIAC DEVICE LEAD EXTRACTION. NATURE REVIEWS CARDIOLOGY. 2016;13(4):221-229.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE LEADS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/MANUFACTURER SERIAL NUMBERS. THIS ARTICLE IS A SUMMARY OF THE "MOST RELEVANT AND CONTEMPORARY DATA ON SAFETY, EFFICACY, AND OUTCOMES OF LEAD EXTRACTION." THE ARTICLE STATED THAT THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE SHOCKS, "INEFFECTIVE SHOCKS," APPARENT FRACTURES, NOISE/OVERSENSING, LEAD RECALLS, AND "SEVERE CLINICAL PRESENTATIONS." THE STATUS OF THE LEADS IS UNKNOWN. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE AUTHOR/PHYSICIAN WHO INDICATED THAT ALL LEAD FAILURES HAVE BEEN "SYSTEMATICALLY" REPORTED TO THE MANUFACTURER. THE INFORMATION IN THE ARTICLE WAS NOT "ORIGINAL DATA ," BUT PREVIOUSLY REPORTED INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509828 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. MDT-FIDELIS-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R