BEUDAMED
    FDA Adverse Event Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1864889 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10905
    Date Received
    October 12, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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; BLOOD PRESENT IN/ON THE HELIX MECHANISM; FULL LEAD ANALYZED.

    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; BLOOD PRESENT IN/ON THE HELIX MECHANISM; FULL LEAD ANALYZED. THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A 3500A REPORT. SECTION F HAS BEEN UPDATED TO REFLECT THAT REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD HAD A DEFECTIVE SCREW MECHANISM OR DEFECTIVE INNER LUMEN. 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 ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other