BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3210153 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06506
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 19, 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

    THE LEFT VENTRICULAR (LV) LEAD REMAINS IN SERVICE AND WAS NOT RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS LEFT VENTRICULAR (LV) LEAD REVEALED HIGH PACING IMPEDANCE GREATER THAN 2,000 OHMS AND HIGH PACING THRESHOLDS. AN X-RAY WAS TAKEN AND REVEALED POSSIBLE LEAD DAMAGE. THE PHYSICIAN SUSPECTED A LEAD FRACTURE NEAR THE SUTURE SLEEVE. THE DEVICE WAS REPROGRAMMED AS ONLY RIGHT VENTRICULAR (RV) PACING IS NEEDED FOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311101 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4591

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R 0171| 4096| 0175| H197| 4591