BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1802754 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08702
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT, AFTER THE PATIENT WAS CLOSED, AN ATRIAL LEAD DISLODGEMENT WAS CONFIRMED WITH A CHEST X-RAY. THE POCKET WAS OPENED AND THE LEAD WAS REPOSITIONED. AT THAT TIME, THE PHYSICIAN ALSO WANTED TO PUT MORE SLACK ON THE VENTRICULAR LEAD, SO IT WAS DETACHED AND REATTACHED. THE PATIENT WENT ASYSTOLIC, THERE WAS A LEAD WARNING AND POLARITY SWITCH; THE DEVICE HAD REVERTED TO UNIPOLAR. WHEN PUT BACK INTO THE POCKET, IT BEGAN TO PACE. WHEN ATTEMPTS WERE MADE TO REPROGRAM THE VENTRICULAR LEAD BACK TO BIPOLAR, THE PATIENT AGAIN WENT ASYSTOLIC. THE DEVICE FAILED TO PACE. LEAD MEASUREMENTS WERE GOOD THROUGH THE ANALYZER, AND THE VENTRICULAR LEAD WAS REINSERTED INTO THE DEVICE, WITH ASYSTOLE AGAIN. THE DEVICE WAS REMOVED AND REPLACED, WITH APPROPRIATE PACING, AND THE LEADS REMAIN IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 5076 IMPLANTABLE PACING LEAD