BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3211630 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09217
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    September 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT THE LEAD WAS RETURNED SEVERED AND IN TWO PIECES. THERE WAS DRIED BLOOD AND BODILY FLUID NOTED THROUGHOUT THE LEAD LUMEN, THE CONDUCTOR COILS WERE FOUND TO BE DEFORMED. ADDITIONALLY THERE WERE SIX SUTURE SLEEVES ON THE LEAD WHICH WERE AFFIXED WITH MEDICAL ADHESIVE. THE ALLEGATIONS WERE NOT CONFIRMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS LEAD WAS EXPLANTED DUE TO MULTIPLE INSULATION ABRASIONS NOTED ON THE LEAD NEAR THE PROXIMAL END.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENTS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES AS WELL AS HIGH THRESHOLDS AND LOSS OF CAPTURE (LOC). THE PATIENT IS GOING TO HAVE A DEVICE REPLACEMENT PROCEDURE SOON, AND THE PHYSICIAN PLANS TO REPLACE THIS LEAD AT THAT TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310358 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 4087| 4555| 4543| H217| 0158| 4193