BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 3092574 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-06911
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THAT THE LEAD'S ANODE CONDUCTOR COIL IS FRACTURED. THE INSULATION IS ABRADED AND TORN WITH THE OUTER CONDUCTOR COIL DEFORMED AND COMPRESSED. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. DUE TO THE TYPE OF DAMAGE IT IS LIKELY THIS WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE OR THE FIRST-RIB REGION. THE ALLEGATION OF A LEAD FRACTURE IS CONFIRMED, AND THE LEAD IS CLINICALLY OUT OF SPECIFICATIONS.

    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 WAS FRACTURED. THIS RV LEAD WAS EXPLANTED AND OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194005 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R 4053| 4034| MISMATCH| 1283| 1298