BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 4161597 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11488
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MPRI
    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
    MN, 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. THE LEAD IS A PART OF THAT RECALL. BASED ON THE INFORMATION THE LEAD DID NOT ACT IN A MANNER CONSISTENT WITH THE RECALL. PRODUCT EVENT SUMMARY: A DISTAL PORTION OF THE LEAD WAS RECEIVED MEASURING 41 CM. THE OUTER INSULATION OF THE LEAD WAS BREACHED DUE TO BI/MULTI-LUMEN TUBING VOIDS WHILE IN VIVO. CONCOMITANT PRODUCTS: PRODUCT ID D224TRK, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2009; 4193, IMPLANTABLE PACING LEAD, (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE REASON THE LEAD WAS EXPLANTED, BUT IT IS NOT AVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641958 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R 2 X 5076 IMPLANTABLE PACING LEADS