BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 20465080 · Received October 16, 2024

    Report

    Report Number
    3004209178-2024-20445
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Report Date
    December 18, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME SPECIFY; PRODUCT ID 3998 (LOT: V855145); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2011; 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 3998 LOT# V855145 SERIAL# IMPLANTED: (B)(6) 2011 EXPLANTED: 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    PATIENT CALLED AGAIN IN REGARDS TO THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED WHERE THE LEAD WIRES GO INTO HIS SPINE HE HAS BEEN HAVING A LOT OF PAIN THAT THEY HAVE NEVER HAD BEFORE SINCE ABOUT A YEAR AGO PATIENT STATED SOMETIMES IT FEELS LIKE THEY ARE BEING ZAPPED IN THERE. PATIENT STATED THEY HAVE HAD A COUPLE OF OCCASIONS WHERE THE WIRE COMES OUT OF THE STIMULATOR THEY FELT A TINGLING ALMOST AS SHOCKING WHERE IT GOES BEHIND HIS RIB CAGE BUT THAT WAS NOT REAL OFTEN ALL SINCE ABOUT A YEAR AGO. PATIENT VERIFIED THEY HAVE NOT HAD ANY TRAUMAS OR FALLS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    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 REPORTED THAT THE AREA WHERE THE WIRES GO INTO THEIR SPINE HAS BEEN HURTING FOR MONTHS AND NOW IT IS BURNING AND HURTING REAL BAD. PATIENT STATED THAT IN THE PAST COUPLE WEEKS IT HAS BEEN A BURNING STABBING PAIN AND IF THEY MOVE IT FEELS LIKE SOMEONE IS GRABBING THEIR SPINE AND RIPPING IT OUT OF THEIR BACK. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT STATED THE ISSUE STARTED A 1-2 YEARS AGO, BUT HAS GOTTEN WORSE IN THE PAST FEW WEEKS.  PT CALLED BACK STATING THEY HAD A LOT OF PROBLEM, THEY FELT HURTING, BURNING, STABBING PAINS.

    Description of Event or Problem · 0

    THE REASON FOR CALL WAS PATIENT REPORTED THE WIRES GOING INTO THE SPINE IS CAUSING EXCRUCIATING PAIN. PATIENT STATED YESTERDAY THEY HAD SHOCK IN THE BACK WHEN THEY BENT TO DO SOMETHING. PATIENT STATED THIS ISSUE HAS BEEN GOING FOR ABOUT A YEAR. PATIENT STATED THEY WANT THE DEVICE REMOVED. PATIENT STATED THE HCP AND HIS WIFE ARE IN JAIL. PATIENT ASKED FOR HCP LISTING. PATIENT STATED HE DID NOT HAVE THE EXTERNAL DEVICES. AGENT EMAILED PHYSICIAN LISTINGS TO PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THEY MENTIONED THEY HAVE BURNING/STABBING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580472 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male "SEE H11...."| SEE H11...