BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1347919 · Received March 10, 2009

    Report

    Report Number
    2649622-2008-01545
    Event Type
    Death
    Date Received
    March 10, 2009
    Date of Event
    December 10, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUDDEN INCREASE IN IMPEDANCE. WHEN THE POCKET WAS OPENED, THE LEAD WAS TWISTED AND KNOTTED DUE TO TWIDDLER'S SYNDROME. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED IN A LAWSUIT ALLEGING THAT THE PATIENT 'EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, OR FAILURE TO RECEIVE THERAPEUTIC SHOCKS', AND THEY REQUIRED MEDICAL INTERVENTION TO REPLACE THE 'DEFECTIVE' LEAD. IT ALSO ALLEGES THAT AS A RESULT, THE PATIENT HAS 'SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES.' ADDITIONAL INFORMATION RECEIVED REPORTED AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT IS DECEASED AND FURTHER INDICATED THAT THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUDDEN INCREASE IN IMPEDANCE. WHEN THE POCKET WAS OPENED, THE LEAD WAS TWISTED AND KNOTTED DUE TO TWIDDLER'S SYNDROME. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ALLEGING THAT THE PATIENT 'EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, OR FAILURE TO RECEIVE THERAPEUTIC SHOCKS', AND THEY REQUIRED MEDICAL INTERVENTION TO REPLACE THE 'DEFECTIVE' LEAD. IT ALSO ALLEGES THAT AS A RESULT, THE PATIENT HAS 'SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB