BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3050084 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03928
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUTS. ALL OTHER LEAD DIAGNOSTICS WERE OBSERVED TO BE WITHIN NORMAL LIMITS. X-RAY IMAGING REVEALED THAT THE LEAD HAD DISLODGED. OF NOTE, THE PATIENT REPORTED HANDLING SEVERAL HEAVY ITEMS THE WEEK PRIOR. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148284 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 4592| 4469| 0184| T125| MISMATCH| N161