BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1924127 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13411
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    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 FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND (B)(4) FULL LEAD (B)(4) NO ANOMALIES FOUND (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PHYSICIAN WAS UNABLE TO PASS THE STYLETS TO REPOSITION THE LEADS FOLLOWING AN INABILITY TO GET ADEQUATE SENSING AND CAPTURE THRESHOLDS. THE LEADS WERE NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 DA Other