BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2121124 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07792
    Event Type
    Injury
    Date Received
    June 13, 2011
    Report Date
    April 23, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO, 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
    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. DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCED "ELECTRICAL TINGLING" AND THE RIGHT VENTRICULAR LEAD HAD FRACTURED. IT WAS ALSO REPORTED THAT A LEAD INTEGRITY ALERT WAS HEARD DAILY. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCED "ELECTRICAL TINGLING" AND THE RIGHT VENTRICULAR LEAD HAD FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD