BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 1862109 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15787
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS EVENT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT BOTH THE ATRIAL AND VENTRICULAR LEADS ON THIS PATIENT EXHIBITED NOISE. THE VENTRICULAR LEAD ALSO HAD INTERMITTENT LOSS OF CAPTURE. BOTH LEADS WERE REMOVED AS WELL AS THE DEVICE, AS THIS PATIENT IS PACEMAKER DEPENDANT AND THE PHYSICIAN WANTED TO AVOID A FUTURE SURGERY. A NEW SYSTEM WAS SUCCESSFULLY IMPLANTED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS 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 68 YR Required Intervention 1230| S606| 4054| 4064| 4269| 4285| 1280| 5076| 4053| 4035