BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1993999 · Received February 16, 2011

    Report

    Report Number
    2649622-2011-00294
    Event Type
    Injury
    Date Received
    February 16, 2011
    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
    MO, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND FOUND HIGH IMPEDANCE >9999 ON BOTH LEADS AS OF (B)(6) 2010. THE DEVICE WAS LATER RETURNED AND ANALYZED. TESTING REVEALED NO PACING OUTPUT AND NO TELEMETRY. THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHORT OF BREATH AND WAS FATIGUED. THE DEVICE WAS INTERROGATED AND NOTED TO HAVE HIGH IMPEDANCE AND WAS NOT SENSING OR PACING. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY FELT VERY SICK ABOUT A WEEK BEFORE REPLACEMENT OF THE DEVICE AND THOUGHT THE LEAD MAY HAVE DISLODGED. THE LEAD REMAINS IN USE. 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 78 YR Hospitalization| R COMPETITOR IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD