BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN STARFIX

    MDR report key: 1862781 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10132
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND, FULL LEAD ANALYZED; (B)(4) NO ANOMALIES FOUND, FULL LEAD ANALYZED; (B)(4) NO ANOMALIES FOUND, FULL LEAD ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LV LEAD (4194) WAS NOT IMPLANTED DUE TO PATIENT ANATOMY. THE LV LEAD (4196) WAS IMPLANTED. THE NEXT DAY THE LEAD MIGRATED AND RESULTING IN PHRENIC NERVE STIMULATION. REPOSITIONING WAS ATTEMPTED, BUT NOT SUCCESSFUL. THE LEAD WAS EXPLANTED. THE LV LEAD (4195) WAS ATTEMPTED BUT STILL RESULTED IN PHRENIC NERVE STIMULATION AND WAS NOT IMPLANTED. A SECOND 4194 WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN STARFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4195 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 8042 IMPLANTABLE PULSE GENERATOR