BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1992678 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02987
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    April 22, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4): ANALYSIS UNKNOWN. NO ANALYSIS WAS PERFORMED DUE TO THE EVENT BEING UNDER LITIGATION. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE ANALYSIS INDICATED THAT THE SUPERIOR VENA CAVA DEFIBRILLATION COIL CONNECTOR WAS EXTRINSICALLY BENT. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE INITIAL REPORTED EVENT WAS PREVIOUSLY SUBMITTED VIA A REMEDIAL ACTION EXEMPTION (RAE) SUMMARY REPORT. THE MANUFACTURER HAS VOLUNTARILY DISCONTINUED THIS RAE, SO SUPPLEMENTAL INFORMATION IS BEING SUBMITTED VIA A 30-DAY REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) PIN ON THE DEFIBRILLATION LEAD WAS "CRIMPED AND BENT." THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 41 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD