BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2051989 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03284
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN EROSION. THE REST OF THE IMPLANTING SYSTEM ARE COMPROMISED OF COMPETITOR PRODUCTS, BUT WAS ALSO EXPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE ASSOCIATED WITH THE EXPLANT PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4)| 4076| 4035| (B)(4)