BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 6920590 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01534
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    January 1, 2017
    Report Date
    July 5, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. 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: SEVERE TRICUSPID VALVE INJURY DURING RIGHT VENTRICULAR LEAD EXTRACTION. JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. 2017; 31(2):626-628.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THE EXTRACTION OF AN IMPLANTABLE TACHY LEAD. THE ARTICLE NOTED AFTER THE LEAD EXTRACTION, THE PATIENT DEVELOPED TRICUSPID REGURGITATION CAUSED BY MECHANICAL AVULSION OF THE SEPTAL VALVE LEAFLETS. THE PATIENT EXPERIENCED MILD HYPOXIA AND TRANSIENT HYPOTENSION REQUIRING INTERVENTION. 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
    702541 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. MDT-FIDELIS-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R