BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS VR COATED

    MDR report key: 1073654 · Received July 8, 2008

    Report

    Report Number
    1028232-2008-00735
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    January 29, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. UPON RECEIPT, AN ELECTRICAL INSPECTION WAS PERFORMED, CONFIRMING THE PACEMAKER WAS NOT INTERROGATABLE. THE REVIEW OF THE PACEMAKER'S MEMORY CONTENT REVEALED INVALID MEMORY CONTENT. THE DEVICE DETECTED THE INVALID MEMORY CONTENT AUTOMATICALLY AND SWITCHED TO A SPECIFIED SECURE BACKUP MODE. IN THIS BACKUP MODE A PROGRAM IS ACTIVE, ENSURING ANTIBRADY PACING. THIS WAS ALSO CONFIRMED BY THE MEASUREMENT OF THE PACEMAKER'S OUTPUT SIGNAL. THERE WAS NO INDICATION OF SENSING AND/OR PACING PROBLEMS. DURING ANALYSIS, A RE-INITIALIZATION HAS BEEN PERFORMED SUCCESSFULLY. AFTER THIS RE-INITIALIZATION, THE PACEMAKER WAS INTERROGATABLE AGAIN AND WAS PACING ACCORDING TO FACTORY SETTINGS. NO SWITCH OF THE PACEMAKER INTO THE BACK UP MODE WAS OBSERVED, SHOWING THAT THE INVALID MEMORY CONTENT WAS NOT CAUSED BY A HARDWARE MALFUNCTION. IT WAS NOT REPORTED WHETHER THE PACEMAKER WAS SUBJECTED TO STRONG EXTERNAL FIELDS (E.G. HF SURGERY OR RADIATION THERAPY). THE QUAL DOCUMENTS ACCOMPANYING THE PACEMAKER HAVE BEEN RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE PRODUCTION AND FINAL ACCEPTANCE TEST OF THE PACEMAKER. THE MEMORY CONTENT DURING THE PRODUCTION AT BIOTRONIK WAS VALID. THIS PACEMAKER DID NOT SHOW A SIGN OF A MATERIAL OR MFG PROBLEMS. THE PACEMAKER WENT INTO BACKUP MODE MOST LIKELY CAUSED BY EXTERNAL INFLUENCES. THE PT'S SAFETY WAS NOT AFFECTED DUE TO THE FULLY FUNCTIONAL SENSING AND PACING.

    Description of Event or Problem · 1

    OUS MDR; IT WAS REPORTED THAT AFTER IMPLANTATION, THE DEVICE COULDN'T BE INTERROGATED. THE DEVICE WAS EXPLANTED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS VR COATED PACEMAKER DXY BIOTRONIK GMBH AND CO. 349813

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization