BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 1850272 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-17201
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PREVIOUSLY CAPPED IMPLANTABLE DEFIBRILLATION LEAD HAD ERODED. A POCKET REVISION PROCEDURE WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 0014

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 1775| 0185| 0064| 1857| 1625| 0181| T177| 0014| 1550