BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1925507 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13907
    Event Type
    Injury
    Date Received
    December 14, 2010
    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
    IN, 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 AND ANALYZED.

    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 AND ANALYZED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE LEAD WAS STRETCHED.

    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 AND ANALYZED. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICLAR LEAD WAS UNABLE TO BE IMPLANTED BECAUSE OF SMALL VENOUS ANATOMY AND IT EXHIBITED HIGH/UNSTABLE THRESHOLDS. THIS LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL LEAD HAD DISLODGED. THIS LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS UNABLE TO BE IMPLANTED BECAUSE OF SMALL VENOUS ANATOMY AND IT EXHIBITED HIGH/UNSTABLE THRESHOLDS. THIS LEAD WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL LEAD HAD DISLODGED. THIS LEAD WAS CAPPED AND REPLACED. IT WAS LATER REPORTED THAT THE RIGHT ATRIAL LEAD WAS REMOVED. NO PATIENT COMPLICATIONS WERE 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. 5068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R (B)(4) HEART VALVE| 4068 IMPLANTABLE PACING LEAD| 4068 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) HEART VALVE| 4068 IMPLANTABLE PACING LEAD| (B)(4) HEART VALVE| (B)(4) IMPLANTABLE PULSE GENERATOR