BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3153510 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06057
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE LEAD WAS RETURNED WITH AN EXTRINSIC CUT/BREACH TO THE OUTER INSULATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2013; 5076 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN PEELED OFF THE SHEATH ON THE ATRIAL LEAD; HOWEVER, THE SHEATH WAS NOT COMPLETELY REMOVED AND THE PHYSICIAN USED A SCISSORS TO PEEL OFF THE REMAINDER. IT WAS DISCOVERED THE LEAD INSULATION WAS DAMAGED. PHYSICIAN STATED THE DAMAGE WAS NOT A RESULT OF THE SCISSORS USE. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258333 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR