BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1861482 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10065
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS POCKET STIMULATION WHICH WAS OBSERVED BY THE COMPANY REPRESENTATIVE. TESTING WAS PERFORMED AT VARIOUS OUTPUTS, PULSE WIDTHS AND POLARITY AND STIMULATION IS EVIDENT AS OUTPUT AND OR PULSE WIDTH IS INCREASED. THE POCKET STIMULATION WAS DUE TO THE VENTRICULAR LEAD VOLTAGES OF GREATER THAN OR EQUAL TO 3.5V. THE POCKET STIMULATION WAS ALLEVIATED BY LOWERING THE VOLTAGE. CAPTURE MANAGEMENT FEATURE WAS LEFT ON AS THE THRESHOLD HAS GONE UP SINCE LAST WEEK. IT WAS QUESTIONED IF THERE WAS A LEAKY GROMMET ON THE DEVICE. THE PHYSICIAN DECIDED TO PERFORM SURGERY TO MANAGE THE ISSUE AND DETERMINED THAT THE DEVICE WAS FINE BUT THE LEAD HAD PERFORATED. THE LEAD WAS CAPPED AND REPLACED. 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 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention 5594 IMPLANTABLE PACING LEAD