BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2790593 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14435
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0068-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT PROCEDURE, THE LEADS WERE CONNECTED TO THE DEVICE AND TESTED. THE RIGHT VENTRICULAR (RV) LEAD COIL IMPEDANCE MEASUREMENT WAS FLUCTUATING AND HIGH. THE PHYSICIAN ALSO HAD DIFFICULTY EXTENDING THE SETSCREW IN THE DEVICE HEADER. AFTER USING SEVERAL SCREWDRIVERS, EVENTUALLY THE PHYSICIAN WAS ABLE TO TURN IT. THE PHYSICIAN BELIEVED THE CAUSE OF THE FLUCTUATING IMPEDANCE MEASUREMENT OF THE RV LEAD WAS DUE TO THE SETSCREW ISSUE IN THE DEVICE HEADER; SUBSEQUENTLY, THE DEVICE WAS REMOVED AND A NEW DEVICE WAS ATTACHED TO THE LEADS. THE LEADS WERE TESTED AND THE FLUCTUATION IN LEAD IMPEDANCE MEASUREMENTS OCCURRED AGAIN. THE DECISION WAS MADE TO CAP THE RV LEAD AND IMPLANT A NEW LEAD. WHEN THE NEW LEAD WAS CONNECTED TO THE DEVICE, ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6931

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 1688TC COMPETITOR IMPLANTABLE PACING LEAD| 4524 COMPETITOR IMPLANTABLE PACING LEAD