BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 1921321 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12456
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P060039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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; THE FULL LEAD WAS RETURNED FOR ANALYSIS. BLOOD/BODY FLUID PRESENT ON THE DISTAL CONDUCTOR. DRIED BLOOD UNDER THE OUTER TUBING OVERLAY, AND IN/ON THE LOBE MECHANISM. APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION AND REQUIRED LEAD REVISION. DURING THE REVISION, THE LEAD LOBES WOULD NOT UNDEPLOY. THE LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 4086 COMPETITIVE IMPLANTABLE PACING LEAD