BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REOCOR D

    MDR report key: 7962318 · Received October 12, 2018

    Report

    Report Number
    1028232-2018-03493
    Event Type
    Injury
    Date Received
    October 12, 2018
    Report Date
    September 25, 2018
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    UDI-DI
    04035479110055
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BECAUSE SERIAL NUMBERS ARE UNKNOWN, WE DO NOT HAVE A MANUFACTURE DATE. THE RE-INSPECTION OF THE RETURNED DEVICES REVEALED SEVERE DAMAGES CAUSED BY STRONG EXTERNAL FORCES, I.E. DROP DAMAGES, IN ALL CASES. THREE DEVICES SHOWED SIGNS OF MANUAL OPENING OF THE HOUSING AND ATTEMPTS TO SELF-REPAIR WERE VISIBLE. ADDITIONALLY, ALL RETURNED DEVICES HAD PENETRATION OF FLUID (E.G. WATER) INTO THE DEVICE HOUSING, WHICH LED TO CORROSION AND EXTENSIVE DAMAGE TO THE INTERNAL CIRCUIT BOARD. IN SUMMARY, ALL DEVICES HAD BEEN RETURNED WITH SEVERE DAMAGES. NO SPECIFIC FAILURE MODE WAS IDENTIFIED AND THERE WAS NO MATERIAL OR MANUFACTURING ISSUE RELATED TO THE RETURNED DEVICES.

    Description of Event or Problem · 1

    WE RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA. THE REPORT WAS SENT IN FROM (B)(6) HEALTH ((B)(4)). THE REPORT IS: WHEN AN (B)(6) YEAR OLD MALE WAS BEING TAKEN OFF THE BYPASS MACHINE AND THE TEAM WAS TRYING TO GET HIS HEART STARTED AGAIN, PACING WIRES WERE INSERTED INTO THE HEART AND CONNECTED TO THE PACING CABLES AND TO THE EXTERNAL PACEMAKER. THE PACING DIDN'T WORK WITH THE FIRST SET OF CABLES AND EXTERNAL PACEMAKER. THE CABLES WERE CHANGED OUT WITH STILL NO CHANGE. THE EXTERNAL PACEMAKER WAS CHANGED OUT WITH STILL NO PACING. EVERYTHING WAS CHANGED OUT 3 TIMES WITH NO SUCCESS. FINALLY THE PHYSICIAN USED A COMPETITOR'S DEVICE AND CABLES AND PACING WAS ACHIEVED. THE HOSPITAL COULD NOT PROVIDE ANY SERIAL NUMBERS IN THIS COMPLAINT. THEY ALSO SAID THAT THE DEVICES WERE RETURNED TO THEIR BIOMED DEPARTMENT AND ALL DEVICES CHECKED OUT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802846 REOCOR D EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365529 04035479110055

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization