BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 19613624 · Received June 26, 2024

    Report

    Report Number
    3004209178-2024-13569
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 2, 2024
    Report Date
    June 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME RESTORE; PRODUCT ID: 37761 (SERIAL: (B)(6); PRODUCT TYPE: 0213-RECHARGER 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. IT WAS REPORTED THAT THE DESKTOP CHARGER (DTC) WAS FRAYED. A REPLACEMENT DESKTOP CHARGER WAS SENT OUT. NO SYMPTOMS WERE REPORTED. (B)(6) 2024. RTG0596412 (CON): ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT (PT). IT WAS REPORTED THAT THEY RECEIVED REPLACEMENT DESKTOP CHARGER AND STATED THAT WAS THE WRONG PART. AGENT ASKED CLARIFYING QUESTION AND PATIENT MENTIONED THERE WAS A METAL PIECE INSIDE THE RECHARGER WHERE THE DESKTOP CHARGER WOULD GO INTO. PATIENT WAS ABLE TO REMOVE THE METAL PIECE AND WAS ABLE TO INSERT/UNPLUG DESKTOP RECHARGER INTO RECHARGER. PATIENT LATER CONFIRMED THAT WAS THE CORRECT PART. THE ISSUE WAS RESOLVED. [SEE GENERAL TEXT INFO FOR DETAILS ON OMITTED INFORMATION.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578030 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female