BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3062227 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05088
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 6, 2013
    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
    MA, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (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

    THE PATIENT REPORTED THAT THE LEAD HAD "PROBLEMS". THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT DUE TO MDT, THE PT HAS 'SUFFERED EXTREME PHYSICAL INJURY AND EXTREME EMOTIONAL AND PSYCHOLOGICAL DISTRESS WHICH INCLUDES AN ACUTE FEAR OF SUDDEN DEATH'. ALSO ALLEGED THAT THE PT HAS 'HEART PALPITATIONS, ANXIETY, AND OTHER DEBILITATING INJURIES......AND SUFFER FROM POST TRAUMATIC STRESS'. THE PATIENT FURTHER REPORTED THAT THE LEAD HAD "PROBLEMS". FOLLOW-UP DETERMINED THAT THERE WAS NOISE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163647 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR