BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 3212962 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09083
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 3, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS FOUND TO HAVE DISLODGED DURING POST OPERATIVE DISCHARGE. THE LEAD WAS REPOSITIONED LATER THE SAME DAY. ONE DAY POST IMPLANT IT WAS NOTED THAT THIS LEAD HAD DISLODGED ONCE AGAIN. THE PHYSICIAN WAS NOT PLANNING TO REPOSITION THE LEAD DUE TO THE PATIENT STATUS. AN INQUIRY WAS MADE TO DETERMINE THE IMPACT OF PERFORMING MRI SCANNING IN THE NEAR FUTURE WITH THE DEVICE PROGRAMMED TO VII. TECHNICAL SERVICES DISCUSSED POSSIBLE INDICATIONS WHEN IT COME TO THE DISLODGED ATRIAL LEAD AND ALSO NOTED THAT A DISLODGED LEAD IS COMPROMISED SYSTEM INTEGRITY AND NOT OPTIMAL REGARDLESS OF WHETHER OR NOT THE PATIENT IS UNDERGOING AN MRI. TECHNICAL SERVICES UNDERSTOOD THE CONDITION OF THE PATIENT WHEN IT COME TO PERFORMING A REVISION AND NOTED THAT IF AN MRI IS NEEDED THIS WOULD BE UP TO THE PHYSICIAN DISCRETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS REPROGRAMMED TO VVI AND NO REPOSITIONING PROCEDURE WAS PERFORMED. THIS RIGHT ATRIAL LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    MDR FILED ERRONEOUSLY ON CLINICAL PRODUCT MONITORED THROUGH IDE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312381 INGEVITY IMPLANTABLE LEAD DTB CPI PLANT - ST. PAUL 7636

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R