BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 3961773 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14510
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETAINED BY THE HOSPITAL. AS THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED. ADDITIONAL INFORMATION INDICATED THAT THE LEAD HAD FRACTURED AND WAS FOUND OUT THROUGH VISUAL INSPECTION DURING THE ELECTIVE REPLACEMENT OF THE DEVICE. THIS RV LEAD WAS REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439335 SELUTE PICOTIP IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4035| 5076| 4440| 4076| 1273| K174| S602| 1296