BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA XT VR

    MDR report key: 2130493 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01084
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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.

    Additional Manufacturer Narrative · 1

    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. 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE PACKAGING WAS DAMAGED. (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE PACKAGING WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE PACKAGING WAS DAMAGED.

    Description of Event or Problem · 1

    ASKU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSPORT, THE PACKAGING ON THE DEVICE WAS DAMAGED AND THE DEVICE CASING WAS CRUSHED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE TWO DEVICES DELIVERED IN A RE-SEALED CARDBOARD BOX. WHEN THE BOX WAS OPENED, THE CASING OF ONE OF THE DEVICES WAS CRUSHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSPORT, THE PACKAGING ON THE DEVICE WAS DAMAGED AND THE DEVICE CASING WAS CRUSHED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other