BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3062153 · Received April 16, 2013

    Report

    Report Number
    9614453-2013-00994
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CONNECTING THE DEVICE TO THE LEAD DURING DEVICE IMPLANTATION, THE "INEXPERIENCED PHYSICIAN PERFORMED THE CONNECTING PROCEDURES BEFORE LETTING THE SET SCREW GET WET WITH SALINE." THE ATRIAL IMPEDANCE WAS DISPLAYED AS OVER 3000." THE ATRIAL LEAD WAS TESTED WITH THE ANALYZER AND THE LEAD ITSELF HAD NO PROBLEM. IT WAS THEN REPORTED THAT THE DEVICE GROMMET COULD BE DAMAGED BECAUSE THE TORQUE WRENCH DIDN'T GET WET WHEN CONNECTING THE DEVICE TO THE LEAD. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163137 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D354TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR