BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 20733270 · Received November 20, 2024

    Report

    Report Number
    3004209178-2024-22324
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 25, 2024
    Report Date
    February 10, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT #: (B)(6). 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.

    Additional Manufacturer Narrative · 0

    H3: THE DEVICE 37761 DESKTOP CHARGER (DTC), SERIAL NUMBER (B)(6) WAS RETURNED FOR PRODUCT ANALYSIS. ANALYSIS FOUND CABLE ASSEMBLY FAILURE AND A FRAYED CORD. H6: SECTION UPDATED. 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

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE. THE CALLER HAD A BROKEN DESKTOP CHARGER. PATIENT REPORTED THAT THE METAL PRONG AT THE TIP OF THE PLUG HAS BROKEN OFF. PATIENT STATED THAT SINCE FRIDAY THEY HAVE HAD A UNIT THAT IS NOT WORKING AND THAT THEY NEED A REPLACEMENT. A REPLACEMENT DESKTOP CHARGER (DTC) WAS SENT OUT. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT STATING THEY RECEIVED THE REPLACEMENT DESKTOP CHARGER TODAY AND IMMEDIATELY STARTED USING IT TO CHARGE THEIR IMPLANT SINCE THE IMPLANT WAS EMPTY AND THEY WERE HAVING A LOT OF PAIN. PATIENT NOTED THAT THE DESKTOP CHARGER BOX WAS GETTING VERY WARM, AND THEY WEREN'T SURE IF IT WAS NORMAL OR IF SOMETHING WAS WRONG. PATIENT STATED THEY WERE ABLE TO RECHARGE THEIR IMPLANT AND NEVER SAW ANY TEMPERATURE ALERTS ON THE SCREEN. PATIENT CONFIRMED THE DESKTOP CHARGER IS CONNECTED DIRECTLY TO AN OUTLET AND NOT AN EXTENSION. PATIENT CONFIRMED THE BOX WAS WARM NOT HOT. AGENT REVIEWED INFORMATION WITH PATIENT AND RECOMMENDED MONITORING THE ISSUE AND CALLING BACK IF IT PERSISTS/WORSENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937924 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male "SEE H11...."