BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 2173795 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11239
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DUE TO EROSION THIS DEVICE SYSTEM WAS PART OF A POCKET REVISION. THE WHOLE SYSTEM WAS REPOSITIONED. WHEN THE PHYSICIAN WAS ENSURING THAT THE RIGHT ATRIAL (RA) LEAD WAS SECURE IN THE HEADER, THE INSULATION ON THE LEAD UNRAVELED AND UNCOILED BETWEEN THE TERMINAL PIN AND THE PROXIMAL RING. THE LEAD WAS CUT AND SURGICALLY ABANDONED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 77 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)