BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 21809632 · Received April 9, 2025

    Report

    Report Number
    3004209178-2025-06181
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    December 31, 2024
    Report Date
    June 23, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS DATE VALID CONTINUATION OF D10: PRODUCT ID 3888-45 LOT# V122051 IMPLANTED: (B)(6) 2009 PRODUCT TYPE LEAD. PRODUCT ID 977A160 SERIAL# (B)(6) IMPLANTED: (B)(6) 2017 PRODUCT TYPE LEAD. PRODUCT ID 977A160 SERIAL# (B)(6) IMPLANTED: (B)(6) 2017 PRODUCT TYPE LEAD. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(6), UBD: 30-MAY-2012, UDI#: (B)(4) ; PRODUCT ID: 977A160, SERIAL/LOT #: (B)(6), UBD: 06-OCT-2020, UDI#: (B)(4) ; PRODUCT ID: 977A160, SERIAL/LOT #: (B)(6), UBD: 06-OCT-2020, UDI#:(B)(4). 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 3888-45, LOT# V122051, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 977A160, SERIAL# (B)(6), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID 977A160, SERIAL# (B)(6), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. 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 WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT WAS NOT ABLE TO CHARGE THE IMPLANT. PATIENT CHARGED EVERY 4-5 DAYS AND COULD NOT HAVE THERAPY OFF FOR ANY AMOUNT OF TIME, NOT EVEN 5 MINUTES, WITHOUT HAVING TERRIBLE PAIN. ON THE CALL INSTRUCTED PATIENT TO PRESS THE GREEN BUTTON AND GO TO CHARGING. PATIENT WAS ABLE TO GET TO CHARGING SCREEN. PATIENT MENTIONED THEY COULD NOT STAND IT BEING OFF ANY LENGTH OF TIME AND DID NOT WANT TO WAIT UNTIL THE IMPLANT COMPLETELY DIES. PATIENT WANTED TO INQUIRE ABOUT INS REPLACEMENT WITH HEALTHCARE PROVIDER (HCP). PATIENT SAID THAT IF THEY HAD THE INS ON, THEIR BLOOD PRESSURE WOULD BE REALLY HIGH. PATIENT SAID THAT IF THEY TURNED OFF THE INS, THEN THEIR BLOOD PRESSURE WOULD BE REALLY LOW. PATIENT WANTED TO KNOW THE INS WAS HITTING A NERVE OR SOMETHING. PATIENT WILL FOLLOW UP WITH HEALTHCARE PROVIDER ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). CALLER REQUESTED MDT REP TO MEET WITH THE PATIENT FOR REPROGRAMMING AS PATIENT THINKS LEADS ARE BROKEN OR HAVE MOVED. CALLER STATED PAIN MANAGEMENT HCP (LISTED IN ORIGINAL NOTE) WOULD LIKE MDT REP TO MEET WITH PATIENT PRIOR TO MOVING TOWARD OTHER OPTIONS. TSS TRANSFERRED CALLER TO NAS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). THEY REPORTED THAT THEY WERE UNABLE TO DETERMINE THE CAUSE OF THE ISSUE. PT REPORTED THEY ARE GETTING THEIR BATTERIES REPLACED SINCE THEY ARE AT EOS AND PT GOT ERI NOTIFICATION ON BOTH BATTERIES. PT NOTED THEY ARE GETTING BOTH BATTERIES REPLACED AND POSSIBLY NEW LEADS. PT NOTED THEIR PAIN WAS GETTING WORSE REGARDLESS OF STIMULATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT STATED THAT THEY WERE GETTING NO LEFT SIDE STIMULATION. THE PATIENT HAD A REVISION PLANNED FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421787 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention "SEE H11...."