BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3153686 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01154
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 29, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 5076 IMPLANTABLE PACING LEAD, (B)(6) 2013. (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: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A LOOSE/DETACHED SET SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE DEVICE WAS BEING INTERROGATED A FEW WEEKS AFTER IMPLANT, JUST AFTER AN IMPEDANCE TEST WAS STARTED BUT WHEN THE PATIENT WAS MORE THAN THREE METERS AWAY FROM THE PROGRAMMER, HIGH PACING IMPEDANCE WAS NOTED. EARLIER WHEN THE PATIENT WAS NEAR THE PROGRAMMER, THE IMPEDANCE VALUES WERE NORMAL. THE PATIENT WAS RELOCATED TO BE NEAR THE PROGRAMMER, AND AGAIN NORMAL IMPEDANCE WAS FOUND. ADDITIONALLY, AN AUDIBLE ALERT WAS HEARD BY THE PATIENT. DURING THE PROCEDURE TO INVESTIGATE THE ISSUE, THE LEAD WAS DISCONNECTED FROM THE DEVICE, CHECKED, AND VALUES WERE NORMAL. THE PHYSICIAN WAS NOT ABLE TO RECONNECT THE LEAD TO THE DEVICE BECAUSE THE SETSCREW WAS DISLODGED AND COULD NOT BE TURNED ANYMORE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254402 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R (B)(4) IMPLANTABLE TACHY LEAD