BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1992634 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02958
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    August 12, 2007
    Report Date
    August 5, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS OVERSENSING, HAD HIGH IMPEDANCE AND THE PATIENT RECEIVED MULTIPLE SHOCKS. IN ADDITION, AN ATTORNEY ALLEGED THE PATIENT WAS SHOCKED 16 TIMES BEFORE HE COULD GET TO THE HOSPITAL TO DISABLE THERAPIES. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT A LAWSUIT ALLEGES THAT THE PATIENT "EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, FRACTURE OR OTHER INJURY." FURTHER REPORTED INFORMATION RECEIVED INDICATED THAT THE LEAD HAD AN APPARENT FRACTURE AND THE LEAD WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ATRIAL LEAD WAS REPLACED DUE TO THE PHYSICIAN "HITTING THE LEAD WITH CAUTERY" DURING THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Life Threatening| H| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB