BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2130618 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10194
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 22, 2011
    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
    MA, 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) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE (S) HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY THAT MAY HAVE OCCURRED.

    Description of Event or Problem · 1

    INFECTION WAS REPORTED. THE DEVICE AND LEADS WERE REMOVED. IT WAS FURTHER REPORTED THAT METHICILLIN RESISTANT STAPH AUREUS BACTEREMIA WAS NOTED. NO FURTHER 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 72 YR Hospitalization| R