BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1864949 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10882
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    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; FULL LEAD ANALYZED. BLOOD OBSERVED IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH IMPEDANCE. THE LEAD WAS CAPPED, THE PHYSICIAN ATTEMPTED TO IMPLANT A NEW 52 CM RV LEAD, BUT DECIDED THAT THE LEAD WAS TOO SHORT, AND IMPLANTED A 58 CM LEAD. 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 69 YR Required Intervention 4568 IMPLANTABLE PACING LEAD| KDR901 IMPLANTABLE PULSE GENERATOR