BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 3041185 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02110
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PHYSICIAN

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WITH ISOMETRICS. THE LEAD WAS FOUND TO BE FRACTURED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143687 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4054

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 4046| 1297| 4053| 4054| 1018T