BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 2123690 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07989
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 3, 2011
    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
    MI, 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) THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. HOWEVER, BLOOD/BODY FLUID WAS NOTED ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, A WHITE SUBSTANCE WAS NOTED ON THE OUTER INSULATION, OUTER INSULATION COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED AND NO ANOMALIES FOUND. HOWEVER, BLOOD/BODY FLUID WAS NOTED ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND THE OUTER TUBING OVERLAY AND BLOOD WAS NOTED IN/ON THE HELIX/LOBE MECHANISM.

    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) THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. HOWEVER, BLOOD/BODY FLUID WAS NOTED ON THE DISTAL AND PROXIMAL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, A WHITE SUBSTANCE WAS NOTED ON THE OUTER INSULATION, OUTER INSULATION COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED AND NO ANOMALIES FOUND. HOWEVER, BLOOD/BODY FLUID WAS NOTED ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND THE OUTER TUBING OVERLAY AND BLOOD WAS NOTED IN/ON THE HELIX/LOBE MECHANISM. (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD POSITIONING/FIXATION DIFFICULTIES AND WAS REPLACED. DURING THE REPLACEMENT ATTEMPT, THE FIRST LEAD COULD NOT BE PLACED DUE TO PATIENT ANATOMY. ANOTHER LEAD WAS IMPLANTED. NO 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 63 YR Hospitalization| O| R 3830 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD| 3830 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD