BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 3043138 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01796
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 31, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD REVEALED THAT THE TERMINAL PIN OF THE LEAD WAS SEPARATED FROM THE TERMINAL RING. THIS DAMAGE IS CONSISTENT WITH AN INADEQUATE BOND BETWEEN THE MEDICAL ADHESIVE ON THE INSULATION AND THE TERMINAL RING. ADDITIONALLY, THE CONDUCTOR COIL(S) WAS/WERE NOTED TO BE SLIGHTLY STRETCHED BETWEEN THE TERMINAL PIN AND TERMINAL RING.

    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 THIS LEAD WAS CAPPED AND ABANDONED DURING A DEVICE CHANGE OUT. THE LEAD HAD PULLED APART AT THE PROXIMAL PORTION THAT IS PLACED IN DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146318 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 1831| T127| 0125| H210| 4269| 4543