BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REOCOR D

    MDR report key: 7962354 · Received October 12, 2018

    Report

    Report Number
    1028232-2018-03492
    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 A (B)(6) YEAR OLD MALE WAS AT A CRITICAL TIME IN THE SURGERY THE EXTERNAL PACEMAKER AND CABLE FAILED TO PROPERLY FUNCTION. THE PATIENT'S HEART QUICKLY DISTENDED AND A HOLE WAS EMERGENTLY MADE IN THE HEART TO DECOMPRESS THE HEART IN ORDER TO SAVE THE PATIENT. ONCE A PROPER FUNCTIONING CABLE AND BOX WERE RETRIEVED (2 BOXES LATER), THE HOLE THAT WAS EMERGENTLY MADE NEEDED TO BE FIXED. (B)(6) HEALTH CANNOT PROVIDE THE SERIAL NUMBERS OF THE EXTERNAL PACEMAKERS THAT WERE USED. (B)(6) HEALTH CLAIMED THAT THE DEVICES WERE SENT TO THEIR BIOMED GROUP WHERE THEY TESTED FINE AND WERE NOT RETURNED TO BIOTRONIK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803559 REOCOR D EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365529 04035479110055

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization