BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3050106 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03948
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT THE LEAD REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THIS LEAD AND IMPLANT A DIFFERENT MODEL BOSTON SCIENTIFIC LV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED LEAD WAS NOT EXPECTED TO BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD REMAINS IN SERVICE UNTIL THE REVISION PROCEDURE CAN BE PERFORMED. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS. CAPTURE WAS OBTAINED AT 7.5V AT 0.5MS. AN X-RAY REVEALED THE LEAD HAD DISLODGED AND WAS PULLED BACK INTO THE CORONARY SINUS. A LEAD REVISION WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148872 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R