BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991314 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02344
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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 THE EVENING OF THE IMPLANT THE ATRIAL LEAD DISLODGED. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. FURTHER TESTING INDICATED THAT THE ATRIAL PORT OF THE DEVICE MAY BE FAULTY. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENING OF THE IMPLANT THE ATRIAL LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. FURTHER TESTING INDICATED THAT THE ATRIAL PORT OF THE DEVICE MAY BE FAULTY. THE DEVICE WAS REMOVED AND 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD