BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 20695581 · Received November 15, 2024

    Report

    Report Number
    3004209178-2024-22107
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Report Date
    January 23, 2025
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3487A-56, LOT# V226418, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. PRODUCT ID 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2009, 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.

    Additional Manufacturer Narrative · 0

    B3: 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 PISCES-QUAD; PRODUCT ID 3487A-56 (LOT: V226418); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE 2009-10-30; EXPLANT DATE BRAND NAME PISCES-QUAD; PRODUCT ID 3487A-56 (LOT: V083355); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2009; EXPLANT DATE. 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

    ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THE PATIENT AND THEIR DOCTORS WERE INVESTIGATING THE BEST WAY TO REMOVE THE DEVICE AND WIRES THEY THOUGHT WERE CAUSING HARM.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THEIR IMPLANT WASN'T VERY EFFECTIVE AFTER ABOUT 4 YEARS SO THEY STOPPED USING IT AND NOW THEIR SYMPTOMS HAD REOCCURRED QUITE A BIT AND THEY WANTED TO GET THE IMPLANT RESTARTED. PATIENT NOTED THEY WOULD LIKE TO USE THE IMPLANT AGAIN BECAUSE OF THEIR PAIN. PATIENT ALWAYS HAD PAIN BUT THE PAIN INTENSIFIED. PATIENT'S IMPLANT WAS IMPLANTED WAY ACROSS THEIR BODY AND THE WIRES CROSSED. AGENT REVIEWED IMPLANT INFORMATION AND REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334532 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

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