BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3993107 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09493
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    May 19, 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
    US
    Reporter Occupation
    PATIENT

    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. OTHER PRODUCT: 5076-52 CRDM NON-DEFIB LEAD IMPLANTED: 2007 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT "THE RIGHT VENTRICULAR (RV) LEAD CAUSED THE PATIENT TO BE COMPLETELY PARALYZED. IT'S BEEN A REALLY BAD THING." THE SPOUSE BELIEVES THAT THERE IS NEGLIGENCE INVOLVED AND STATED THAT THEY WENT TO 8 DIFFERENT LAWYERS TO DISCUSS THE LAWSUIT. FOLLOW UP WITH THE PATIENT'S PHYSICIAN WAS CONDUCTED AND THE PATIENT HAS NOT BEEN SEEN SINCE THE LEAD WAS IMPLANTED. THE PHYSICIAN'S STAFF WAS UNAWARE OF A LEAD OR PRODUCT MALFUNCTION. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468677 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR (B)(4) ICD