BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT FIDELIS

    MDR report key: 3860672 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05340
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF EITHER THE PRODUCT OR PERFORMANCE DATA, OR COMPLETION OF ANALYSIS, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR), THE PHYSICIAN ACCIDENTALLY CONNECTED THE SVC (SUPERIOR VENA CAVA) COIL DF-1 PIN TO THE RV (RIGHT VENTRICULAR) IS-1 CONNECTOR. THIS WAS CORRECTED AND AFTERWARDS THE IMPEDANCE WAS HIGHER AS COMPARED TO THE OLD DEVICE, AND THE RV PACING THRESHOLD WAS ALSO HIGHER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED, WITH THE LEAD LEFT IN USE. AFTER THE PROCEDURE, THE PHYSICIAN SUSPECTED THAT HE DID NOT UNSCREW THE SETSCREW FOR THE RV IS-1 CONNECTOR ENOUGH TO PUSH IN THE LEAD PIN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339782 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR DTBC2D1 IMPLANTABLE CRT-D