BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPPATCBL 2.0 6FT W 8PK

    MDR report key: 17458064 · Received August 4, 2023

    Report

    Report Number
    0002242056-2023-00024
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    July 14, 2023
    Report Date
    May 1, 2024
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    IKD
    UDI-DI
    20841291105265
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: AUSTRALIA. D2: DEVICE PRODUCT CODE: IKD. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H4, H6, H10 D2: DEVICE PRODUCT CODE: IKD NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UNKNOWN PRODUCT WAS RETURNED FOR THIS COMPLAINT: UPON REVIEW IT WAS DETERMINED THAT THE ITEM RETURNED FROM THE REPORTER IS NOT ITEM# 019530 LOT# 06498 AS REPORTED IN THE PER AND IS NOT ASSOCIATED WITH ANY ZIMMER BIOMET PRODUCTS. FURTHER, NO PHOTOGRAPHS OF THE AFFECTED DEVICES WERE INCLUDED IN THIS COMPLAINT SUBMISSION. AS SUCH, NO DEFINITIVE STATEMENTS CAN BE MADE REGARDING CONDITION OF THE PRODUCT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED SENSING FAILURE DURING AN URGENT CATH LAB PROCEDURE. AFTER SWAPPING THE PACING WIRES, AND EVENTUALLY SWAPPING THE PATIENT CABLE, SENSING WAS ACHIEVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334189 DISPPATCBL 2.0 6FT W 8PK CABLE, ELECTRODE IKD A&E MEDICAL CORPORATION NI 06498 20841291105265
    874829 DISPPATCBL 2.0 6FT W 8PK CABLE, ELECTRODE IKD A&E MEDICAL CORPORATION NI 06498 20841291105265

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other