BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3040738 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01541
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL'S INTENSIVE CARE UNIT FOR EXACERBATION OF HIS CONGESTIVE HEART FAILURE (CHF) SYMPTOMS. UPON INTERROGATION THE LEFT VENTRICULAR (LV) LEAD WAS NOTED TO EXHIBIT LOSS OF CAPTURE. INITIALLY THE LEAD WAS REPROGRAMMED WITH THE OUTPUTS TO 7.5 VOLTS AT 2 MS, HOWEVER THE CLINICIAN REQUESTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) HELP IN PROGRAMMING THE LV LEAD OFF. TS ASSISTED THE CLINICIAN WITH ELECTRICALLY ABANDONING THE LV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143294 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R 4087| 4592| 1290| N119| 4088| 7120