BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT CABLE

    MDR report key: 20135030 · Received September 4, 2024

    Report

    Report Number
    2182208-2024-03803
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 4, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSA
    PMA / PMN Number
    K203556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 5492VL 230814 PRODUCT ID 5492VL LOT# 2111096 PRODUCT ID 5492VL LOT# 2209200. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CABLE'S SCREW TO TIGHTEN THE INTERNAL CABLE OF THE PROBE BROKE. IT WAS FURTHER REPORTED THAT THE CABLES WERE WORN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882289 PATIENT CABLE CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INC DSA MEDTRONIC, INC. 5492VL 2308145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown