BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 2183580 · Received July 29, 2011

    Report

    Report Number
    2124215-2011-12814
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    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 THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO POCKET EROSION.

    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 62 YR Life Threatening| R 4054| H135| 4513| H215| 0148