BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 2646500 · Received July 9, 2012

    Report

    Report Number
    6000094-2012-01386
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HIGH SUPERIOR VENA CAVA (SVC) IMPEDANCE MEASUREMENT SUDDENLY WHICH TRIGGERED A PATIENT ALERT. THIS PATIENT, DUE TO SIZE, HAS A HIGH VOLTAGE COIL ADDED TO THE DEVICE AND A PIN PLUG WAS INSERTED IN THE SVC PORT. UP UNTIL THIS INCIDENT THE DEVICE MEASUREMENTS HAD RECOGNIZED CORRECTLY THAT THE PATIENT DID NOT HAVE SCV LEAD. A DEVICE UPDATE MAY BE NEEDED. THE DEVICE REMAINS IN USE, AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D354VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other