BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3992576 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09795
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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
    FL, 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. THE PRODUCT IS A PART OF THE FIELD ACTION, HOWEVER, WITHOUT THE RETURNED PRODUCT THERE IS NO WAS TO DETERMINE IF THE LEAD DISPLAYED CHARACTERISTICS AS OUTLINED IN THE FIELD ACTION. CONCOMITANT MEDICAL PRODUCTS: D284DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2010. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A COMPLAINT OF CHEST PAIN AND THAT THE LEAD IMPEDANCE ALERT TRIGGERED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACE/SENSE IMPEDANCE, NO CAPTURE, HIGH AND UNSTABLE THRESHOLDS, OVERSENSING WITH A HIGH NUMBER OF SHOULD V-V- INTERVALS, NOISE AND WAS FRACTURED. THE RV LEAD WAS DISABLED AND WAS ATTEMPTED TO BE REPLACED, HOWEVER, THE PHYSICIAN ABANDONED THE REPLACEMENT PROCEDURE PHYSICIAN ABORTED EXTRACTION DUE TO DROP IN HEMOGLOBIN AND CONCERN THAT PATIENT MIGHT BE BLEEDING INTERNALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469730 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD