BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 3071828 · Received April 22, 2013

    Report

    Report Number
    9614453-2013-01025
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 1, 2012
    Report Date
    February 21, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS POST IMPLANT THE PATIENT CONTACTED THE HOSPITAL DUE TO A HEMATOMA PRESENT AT THE INCISION SITE. THE PATIENT WAS SEEN AND A COMPRESSIVE BANDAGE WAS DONE FOR FORTY-EIGHT HOURS. A FEW DAYS LATER, AT THE PATIENT'S FOLLOW UP VISIT THE HEMATOMA WAS STILL PRESENT BUT HAD NOT WORSENED. THE PATIENT WAS THEN SCHEDULED TO BE SEEN AT THE PACEMAKER CLINIC THE FOLLOWING MONTH. AT THAT VISIT IT THE INCISION SITE WAS EXAMINED AND THE HEMATOMA HAD SPONTANEOUSLY DRAINED. NO FURTHER INTERVENTION WAS NEEDED. THE DEVICE REMAINS IN USE. THE PATIENT IS ENROLLED IN THE SYSTEMS LONGEVITY STUDY (SLS). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171844 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D354VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention