BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 2151503 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-09701
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATIONS OF A FRACTURE. COMPLETE LEAD WAS RETURNED, UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS X-RAYED NO FRACTURE WAS IDENTIFIED. VISUAL OBSERVATION NOTED DRIED BODY TISSUE ENTWINED ON THE HELIX. CUTS WERE NOTED IN THE INSULATION AT 186, 188, 330, 333 AND 387, 390 MILLIMETERS FROM THE TERMINAL PIN.

    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 RIGHT ATRIAL (RA) LEAD HAD SUSTAINED SUBCLAVIAN DAMAGE RESULTING IN A FRACTURE TO THE LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R S606| 4035| 1280| 1888TC| 4054| 4470| S602