BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 18990382 · Received March 28, 2024

    Report

    Report Number
    3004209178-2024-07964
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 7, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    CONTINUATION OF D10: PRODUCT ID 37761 LOT# SERIAL# (B)(6): PRODUCT TYPE RECHARGER H3: ANALYSIS OF THE DESKTOP CHARGER FOUND NO ANOMALIES WERE VISUALLY OBSERVED. REPLACED CABLE ASSEMBLY DUE TO FRAYED CORD. 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 CONNECTOR PIN 37761 / NO DESKTOP CHARGER CORD DURING THE CALL. PATIENT REPORTED THEY WERE IN THE HOSPITAL BED (PATIENT WAS IN THE HOSPITAL FOR CANCER) AND THE DESKTOP CHARGER GOT CAUGHT BETWEEN THE RAILING. METAL PIN BROKE OFF AND WAS STUCK IN THE RECHARGER PORT. ISSUE BEGAN TODAY. PATIENT WAS ABLE TO REMOVE THE METAL PIN FROM THE RECHARGER PORT AND THERE WERE NO DAMAGES IN THE RECHARGER PORT BLACK PIN. PATIENT DID NOT HAVE THE DESKTOP CHARGER WITH THEM. AGENT ADVISED PATIENT TO CALL BACK ONCE THEY HAD THE DESKTOP CHARGER. PATIENT CALLED BACK AND PROVIDED DTC SERIAL NUMBER. AGENT SENT EMAIL TO REPAIR TO REPLACE THE CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370977 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male "SEE H11...."