BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 3910536 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-12209
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER WAS UNSUCCESSFUL. ALL AVAILABLE INFORMATION SUGGESTS THE PRODUCT REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388398 SELUTE PICOTIP IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4035

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 1273| 4035| 4271