BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3861167 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07381
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THIS LEAD WAS PREVIOUSLY SUBMITTED VIA A TIMELY REMEDIAL ACTION EXEMPTION REPORT ON (B)(4) 2013 FOR INAPPROPRIATE THERAPY. THE LEAD WAS REPROGRAMMED AND REMAINED IN USE. INFORMATION WAS RECEIVED ON (B)(4) 2014 AND REPORTED THE LEAD WAS REMOVED DUE TO INFECTION. THE ADDITIONAL INFORMATION DOES NOT QUALIFY FOR REMEDIAL ACTION EXEMPTION REPORTING AND IS THEREFORE BEING SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. IT WAS NOTED THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO PULLING/ STRETCHING/ OVERSTRESS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCTS: DTBB1D1 ICD IMPLANTED: (B)(6) 2014; 429688 LEAD IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION. THE LEAD WAS REMOVED 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
    341895 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R 5054-58 LEAD, 5568-53 LEAD