BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3023675 · Received March 27, 2013

    Report

    Report Number
    2649622-2013-02577
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 23, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, WAS ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (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 THE PATIENT RECEIVED EIGHT SHOCKS AND THAT A LEAD INTEGRITY ALERT. IT WAS FURTHER REPORTED THAT THERE WAS HIGH IMPEDANCE, OVERSENSING, NOISE AND A FRACTURE WAS SUSPECTED OF THE RIGHT VENTRICULAR LEAD. DURING EXTRACTION OF THE PACING AND TACHY LEADS THE PATIENT HAD A DECREASE IN VITAL SIGNS AND WAS TAKEN URGENTLY TO SURGERY. THE LEADS WERE REMOVED AND REPLACED AND THE PATIENT WAS TAKEN TO INTENSIVE CARE. THE CURRENT STATUS OF THE PATIENT HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED EIGHT SHOCKS AND THAT A LEAD INTEGRITY ALERT OCCURRED. IT WAS FURTHER REPORTED THAT THERE WAS HIGH IMPEDANCE, OVERSENSING, NOISE AND A FRACTURE WAS SUSPECTED OF THE RIGHT VENTRICULAR LEAD. DURING EXTRACTION OF THE PACING AND TACHY LEADS THE PATIENT HAD A DECREASE IN VITAL SIGNS AND WAS TAKEN URGENTLY TO SURGERY. THE LEADS WERE REMOVED AND REPLACED AND THE PATIENT WAS TAKEN TO INTENSIVE CARE. THE CURRENT STATUS OF THE PATIENT HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125456 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Hospitalization| L| R