BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 1873999 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18008
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    November 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POCKET WAS OPENED FOR AN UNRELATED ISSUE. DURING THIS PROCEDURE, THE LEAD WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. AS OF TODAY, THE EXPLANTED LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED FOR ANALYSIS. ANALYSIS IS ON GOING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, VISUAL INSPECTION OF THE LEAD NOTED SEVERAL INDUCED CUTS IN THE INSULATION. THE CLINICAL OBSERVATION OF LEAD DISLODGEMENT COULD NOT BE CONFIRMED. THE LEAD MET ELECTRICAL SPECIFICATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD HAD PULLED BACK HOWEVER WAS STILL APPROPRIATELY PACING.

    Description of Event or Problem · 1

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    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR N119| H217| H227| 0185| 4538| 7121| MISMATCH| (B)(4)| 4470| 4542| 4592| 4537