BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 20307542 · Received September 26, 2024

    Report

    Report Number
    3004209178-2024-19235
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 2, 2024
    Report Date
    September 26, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ID: 37761, SERIAL/LOT #: (B)(6) WAS RETURNED AND THE ANALYSIS REPORT SHOWS BENT/ BROKEN CONNECTOR PINS AT THE END OF CABLE. 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 DESKTOP CHARGER WHERE THE METAL PIECE BROKE OFF INTO THE RECHARGER. PATIENT REPORTED THAT THE CONNECTOR PIN BROKE OFF INSIDE THE RECHARGER YESTERDAY. PATIENT STATED THAT THEY WERE ABLE TO REMOVE THE METAL PIECE FROM THE RECHARGING DEVICE, BUT THEY COULDN'T CHARGE THE DEVICE UNTIL THEY GOT A NEW DESKTOP CHARGER CORD. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098228 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male