BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 17969632 · Received October 19, 2023

    Report

    Report Number
    3004582654-2023-00034
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    October 13, 2023
    Report Date
    June 20, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N, (B)(6) ON THE PATIENT WAS IN USE FROM (B)(6) 2023 UNTIL THE TIME OF THE INCIDENT ON (B)(6)2023 (76 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(6), THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Additional Manufacturer Narrative · 0

    DATA CORRECTED IN SECTION D TO MATCH DEVICE INFORMATION IN GUDID PER THE FDA LETTER DATED 5/20/2024. D1 CHANGED THE BRAND NAME TO MATCH GUDID. D2A CHANGED THE COMMON DEVICE NAME TO MATCH GUDID. D4 UDI CHANGED, TO INCLUDE COMPLETE UDI NUMBER (B)(4).

    Description of Event or Problem · 0

    BERLIN HEART CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC THAT A PATIENT SUFFERED FROM SMALL ISCHEMIC STROKE WITH RIGHT HEMIPARESIS ON (B)(6) 2023. THERE WERE NO CEREBRAL EDEMA. THE PATIENT HAD SYMPTOMS OF NEURO IRRITABILITY 48 HR PRIOR TO THE EVENT. THE PATIENT DEVELOPED THE RIGHT SIDED WEAKNESS ON THE TIME OF THE EVENT. CT-SCAN SHOWED AN AREA OF HYPODENSITY IN LEFT LENIFORM NUCLEUS- POSSIBLY ISCHEMIC IN NATURE. ANOTHER FOCAL AREA OF HYPODENSITY IN RIGHT CAUDATE NUCLEUS. THERE WERE NO INTRACRANIAL BLEEDING AND NO MIDLINE SHIFT. ACCORDING TO THE UPDATED INFORMATION ON 2023-10-16 THE PATIENT GOT STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078278 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Female Other