BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 19651004 · Received July 1, 2024

    Report

    Report Number
    3004209178-2024-13941
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Report Date
    July 1, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. CONTINUATION OF D10: PRODUCT ID 97715 ((B)(6)); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE (B)(6) 2024; EXPLANT DATE SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME VECTRIS SURESCAN; PRODUCT ID 977A290 (SERIAL: (B)(6)); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2020; EXPLANT DATE BRAND NAME VECTRIS SURESCAN; PRODUCT ID 977A290 (SERIAL: (B)(6)); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2020; BRAND NAME SPECIFY SURESCAN; PRODUCT ID 977C165 (SERIAL: (B)(6)); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2017; 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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER STATED BOTH INSS WERE REPLACED TODAY WITH INTELLIS BATTERIES AND UPON CHECKING IMPEDANCES, THE CERVICAL INS THAT WAS CONNECTED TO PERC LEADS HAD HIGH IMPEDANCES ON CONTACT 1 (23910 OHMS) AND THE THORACIC INS CONNECTED TO PADDLE LEAD HAD HIGH IMPEDANCES ON CONTACTS 0-7 (AROUND 30K OHMS). CALLER STATED THEY JUST TOOK A PICTURE OF THE IMPEDANCES WITH THEIR PHONE AND DIDN'T CHECK VARIOUS REFERENCE ELECTRODES SO TSS ASSUMED THE VALUES PROVIDED WERE WITH REFERENCE ELECTRODE AS 0. CALLER STATED HCP DECLINED TO REPLACE LEADS TODAY SO THEY WILL ATTEMPT TO PROGRAM VIABLE LEADS FOR COVERAGE AND GO FROM THERE. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. CALLER WILL NOT BE RETURNING ANY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565645 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

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