BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153560 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06109
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: (B)(4) COMPETITOR IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : A PROXIMAL PORTION WAS RECEIVED MEASURING 36.5 CM. A DISTAL PORTION WAS RECEIVED MEASURING 36.5 CM. THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. IT WAS NOTED THAT THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY CUT BUT NOT BREACHED, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY MELTED BUT NOT BREACHED, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE OUTER INSULATION BREACHED CUT EXTRINSICALLY AND BLOOD WAS INGRESSIVE ALONG LEAD LENGTH. ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATIONS, LIKELY BECAUSE THE LEAD WAS TESTED DRY. HOWEVER, THE INSULATION BREACH LIKELY DID CONTRIBUTE TO THE ELECTRICAL COMPLAINT AND IT APPEARS TO HAVE BEEN CAUSED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A "THUMPING" IN THEIR CHEST. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDANCE WHICH CAUSED A SWITCH FROM BIPOLAR PACING CONFIGURATION TO UNIPOLAR PACING CONFIGURATION, OVERSENSING WAS NOTED AND ALSO OBSERVED DURING POCKET MANIPULATION AND A LEAD FRACTURE WAS SUSPECTED. ADDITIONALLY, THE LEAD HAD HIGH THRESHOLDS IN UNIPOLAR PACING CONFIGURATION AND THE PATIENT WAS EXPERIENCING POCKET STIMULATION. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    CORRECTION: IT WAS THE RIGHT ATRIAL (RA) LEAD THAT WAS EXPLANTED AND REPLACED RATHER THAN THE RV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258360 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R (B)(4) COMPETITOR IMPLANTABLE PULSE GENERATOR