BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812654 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16691
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND NO ANOMALIES. THE ANALYST COMMENTED THAT REVIEW SAVE TO DISK FILE TAKEN DURING RETURN PRODUCT ANALYSIS OF THE DEVICE FOUND THAT THE ATRIAL PACING WAS AT 3.5 VOLTS AT 200 MILLISECONDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL (RA) LEAD HAD A VERY HIGH THRESHOLD POST IMPLANT. IT WAS NOTED THAT DUE TO A DIAGNOSIS OF STOMACH CANCER AND A POOR PROGNOSIS IT WAS DECIDED TO NOT INTERVENE AT THAT TIME. ULTIMATELY THE PATIENT'S CONDITION IMPROVED, SO AT A ROUTINE DEVICE CHANGE OUT THE RA LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB