BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE

    MDR report key: 1924551 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13611
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    June 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S9
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEWLY IMPLANTED RIGHT VENTRICULAR LEAD WAS DISLODGED WHILE ATTEMPTING TO IMPLANT ANOTHER LEAD. THE RIGHT VENTRICULAR LEAD WAS REPOSITIONED AND IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALLINE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. ICF09B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R