BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALLINE

    MDR report key: 1861759 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10109
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 12, 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IMPEDANCE INCREASED IN BIPOLAR CONFIGURATION. THE THRESHOLDS ALSO WERE REPORTED AS INCREASING. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IMPEDANCE INCREASED IN BIPOLAR CONFIGURATION. THE THRESHOLDS ALSO WERE REPORTED AS INCREASING. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT HAS FURTHER BEEN REPORTED THAT THE LEAD HAS BEEN CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN 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 82 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR