BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2051435 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05555
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THER OUTER INSULATION HAD A WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    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, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THER OUTER INSULATION HAD A WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD PREVIOUSLY CAUSED DIAPHRAGMATIC STIMULATION AND HAD BEEN PROGRAMMED OFF. THE LEAD SUBSEQUENTLY DISLODGED, WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL LEAD HAD FAR FIELD R WAVE OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD PREVIOUSLY CAUSED DIAPHRAGMATIC STIMULATION AND HAD BEEN PROGRAMMED OFF. THE LEAD SUBSEQUENTLY DISLODGED, WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL LEAD HAD FAR FIELD R WAVE OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED BY THE REVERSE STUDY THAT THE RIGHT ATRIAL LEAD WAS DISLODGED DURING THE REMOVAL OF THE SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB