BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 25159210 · Received May 13, 2026

    Report

    Report Number
    3004209178-2026-08173
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 17, 2023
    Report Date
    May 13, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NEU_LABEL_ACC, LOT#SERIAL#: UNKNOWN, PRODUCT TYPE: ACCESSORY. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_LABEL_ACC, SERIAL/LOT#: UNKNOWN. 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 THE LEGAL REPRESENTATIVE OF A PATIENT WHO WAS IMPLANTED WITH MULTIPLE IMPLANTABLE NEUROSTIMULATORS (INS). THE ATTORNEY ALLEGED THAT THE PATIENT WANTED TO HOLD THE MANUFACTURER ACCOUNTABLE FOR ¿KNOWINGLY ABUSING THE FEDERAL REGULATORY PROCESS TO MARKET AND DISTRIBUTE AN ADULTERATED SPINAL CORD STIMULATOR SYSTEM WITHOUT WARNING TO DOCTORS OR THE GENERAL PUBLIC¿ AND THAT THE PATIENT EXPERIENCED PERSONAL INJURIES SUSTAINED BECAUSE OF THE MANUFACTURER¿S ¿DEFECTIVE SPINAL CORD STIMULATOR DEVICE.¿ THE PATIENT WAS IMPLANTED WITH TWO DIFFERENT NEUROSTIMULATOR DEVICES. ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH A LUMBAR NEUROSTIMULATOR AND THEN ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH A CERVICAL NEUROSTIMULATOR. THE ATTORNEY NOTED THAT BOTH MODELS WERE APPROVED UNDER PMA P840001 AND WERE ¿SUPPLEMENTED THROUGH A SERIES OF STREAMLINED FDA PROCESSES THAT DID NOT REQUIRE NEW CLINICAL TESTING, INCLUDING 30-DAY NOTICES AND REAL-TIME REVIEW PATHWAYS.¿ THE ATTORNEY ALLEGED THAT MAUDE REPORTS ASSOCIATED WITH THE PATIENT¿S INS MODEL NUMBER INCLUDED ¿MORE THAN 2,700 UNIQUE ADVERSE EVENTS BETWEEN 2017 AND 2022, WITH RECURRING PATTERNS OF HIGH-FREQUENCY CHARGING FAILURE, UNINTENTIONAL SHOCKS, AND STIMULATOR MIGRATION. THESE RISKS WERE NOT ADEQUATELY DISCLOSED IN THE LABELING, TRAINING MATERIALS, OR RISK MITIGATION STRATEGIES ACCOMPANYING THE DEVICE.¿ THE ATTORNEY ALLEGED THAT THE MANUFACTURER¿S POST-APPROVAL MODIFICATIONS TO THE INS SYSTEM ¿INCLUDING FIRMWARE, WIRELESS CONTROL PROTOCOLS, BATTERY MANAGEMENT ALGORITHMS, STIMULATION PARAMETERS, AND PHYSICAL FORM FACTOR, WERE IMPLEMENTED THROUGH SUCCESSIVE PMA SUPPLEMENTS WITHOUT NEW CLINICAL TRIALS OR COMPARATIVE TESTING. THESE CHANGES MATERIALLY ALTERED THE SAFETY AND FUNCTIONALITY PROFILE OF THE SYSTEM BUT WERE NOT DISCLOSED TO PHYSICIANS OR PATIENTS.¿ THE ATTORNEY ALLEGED THAT THE INS IMPLANTED IN THE PATIENT BORE ¿NEGLIGIBLE RESEMBLANCE¿ TO THE INS ORIGINALLY REVIEWED BY THE FDA AND THE BY 2022, THE MANUFACTURER ¿WAS AWARE THROUGH INTERNAL COMPLAINT TRACKING AND POST-MARKET SURVEILLANCE OF NUMEROUS REPORTS OF EARLY-ONSET PAIN FLARE-UPS, ELECTRICAL SHOCKS, AND UNINTENDED STIMULATION¿ RELATED TO THE INS SYSTEM. THE ATTORNEY ALLEGED THAT THE MAUDE DATABASE INCLUDED ¿CONSISTENT ADVERSE EVENT NARRATIVES DESCRIBING ¿SHOCK-LIKE SENSATIONS,¿ ¿BURNING PAIN WORSE THAN BEFORE THE IMPLANT,¿ ¿RAPID LOSS OF CHARGE,¿ AND ¿NON-FUNCTIONAL DEVICES WITHIN MONTHS OF IMPLANTATION.¿¿ IT WAS NOTED THAT THE MANUFACTURER HAD A CONTINUING OBLIGATION TO REVISE ITS PRODUCT LABELING TO REFLECT NEW OR EVOLVING SAFETY INFORMATION AND TO SUBMIT A NEW PMA WHEN THE CUMULATIVE EFFECT OF DEVICE MODIFICATIONS MATERIALLY ALTERED THE SAFETY OR EFFECTIVENESS OF THE SYSTEM; THE ATTORNEY ALLEGED THAT THE MANUFACTURER ¿FAILED TO COMPLY WITH EACH OF THESE OBLIGATIONS.¿ THE PATIENT DEALT WITH CRPS THAT CAUSED LONG LASTING AND INTENSE PAIN THAT LEFT THEM SEARCHING FOR ANY METHOD THAT COULD RELIEVE THEIR PAIN. THE PAIN WAS SO BAD, THE PATIENT HAD TO START USING A WHEELCHAIR IN FEBRUARY 2022. AFTER CONSERVATIVE THERAPIES FAILED TO CONTROL THEIR PAIN, THE PATIENT UNDERWENT A MEDTRONIC SPINAL CORD STIMULATOR TRIAL, WHICH WAS DEEMED SUCCESSFUL ACCORDING TO THE IMPLANTING PHYSICIAN, BECAUSE THEY FELT A 70-75% REDUCTION IN PAIN. ON OR ABOUT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR THE IMPLANTATION OF TWO SURGICAL LEADS AND AN INS. THE ATTORNEY ALLEGED THAT ¿UPON INFORMATION AND BELIEF, BASED ON A REVIEW OF PUBLICLY AVAILABLE REGULATORY DATA¿ THAT THE INS IMPLANTED IN THE PATIENT ¿WAS NOT THE SAME DEVICE THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPROVED UNDER PMA P840001 IN 1984. RATHER, IT WAS A MATERIALLY MODIFIED AND ADULTERATED VERSION INTRODUCED THROUGH AN ACCUMULATION OF IMPROPERLY REVIEWED PMA SUPPLEMENTS, INCLUDING UNAPPROVED FIRMWARE AND HARDWARE CHANGES.¿ AFTER THE PATIENT¿S IMPLANT, THE SPINAL STIMULATOR WORKED JUST AS ADVERTISED. IT REGULATED THEIR PAIN, AND THE PATIENT FELT LIKE THE STIMULATOR WAS DOING ITS JOB IN GIVING THEIR LIFE BACK. ON OR ABOUT ON (B)(6) 2023, THE PATIENT NOTICED AN INCREASE OF PAIN IN HER BACK. THEY ALSO NOTICED THAT WHEN THEY USED THEIR WHEELCHAIR, THEIR LOWER RIGHT EXTREMITIES BEGAN TO HURT WHEN THEY HAD NOT BEFORE. ON OR ABOUT ON (B)(6) 2023, THE PATIENT AND THEIR PHYSICIAN DISCOVERED THAT THEIR CRPS WAS PROGRESSING THROUGHOUT THEIR BODY, AND THEY HAD BORDERLINE ULNAR NEUROPATHY. THE PATIENT UNDERWENT A SECOND SURGERY TO HAVE A CERVICAL SPINAL STIMULATOR IMPLANTED ON (B)(6) 2023. THE PATIENT UNDERWENT A SEPARATE TRIAL PROCESS FOR THE CERVICAL STIMULATOR BEFORE IMPLANTATION WHERE THEIR PAIN AGAIN WAS REDUCED BY 70-75%. AFTER THIS SECOND IMPLANT, THIS INS WORKED JUST AS ADVERTISED. IT REGULATED THEIR PAIN, AND THE PATIENT FELT LIKE THE INS WAS DOING ITS JOB IN RESOLVING THE ISSUES THAT PREVIOUSLY EXISTED. ON OR ABOUT ON (B)(6) 2024, THE PATIENT WENT TO THEIR DOCTOR TO DETERMINE THE CAUSE OF BLISTERS FILLED WITH FLUID THAT HAD REPEATEDLY BEEN APPEARING ALL OVER THEIR BODY, EVER SINCE THE CERVICAL SPINAL STIMULATOR WAS IMPLANTED. ON OR ABOUT ON (B)(6) 2025, THE PATIENT¿S DOCTOR NOTED THAT THEIR RECENT PAINFUL DEFECATION, RECTAL BLEEDING, AND OTHER SYMPTOMS BEGAN WHEN THE NEUROSTIMULATOR THAT WAS IMPLANTED FOR THEIR CPRS FAILED. ON OR ABOUT ON (B)(6) 2025, THE DAMAGE DONE BY THE DEFECTIVE SPINAL STIMULATORS LEAD TO A DIAGNOSIS OF GASTROPARESIS. THE ATTORNEY ALLEGED THAT THE PATIENT¿S BOWEL DYSFUNCTION CAUSED BY THE MALFUNCTION OF BOTH SPINAL STIMULATORS CONTINUED TO THIS DAY. AT NO POINT HAD EITHER DEVICE BEEN REMOVED, AND BOTH REMAIN IN THE PATIENT¿S BODY CONTINUING TO FURTHER DAMAGE THEIR BODY. THE ATTORNEY ALLEGED THAT THE MANUFACTURER¿S MARKETING, LABELING, AND DEVICE DOCUMENTATION PROVIDED TO THE PATIENT AND THEIR HEALTHCARE PROVIDERS ¿DID NOT DISCLOSE THAT THE DEVICE¿S DESIGN AND FIRMWARE HAD BEEN REPEATEDLY MODIFIED THROUGH A PMA SUPPLEMENT PROCESS THAT EVADED THE STATUTORY REQUIREMENT FOR NEW PMA REVIEW¿ AND THAT THE MANUFACTURER DID NOT ¿DISCLOSE THAT THESE MODIFICATIONS WERE NEVER INDEPENDENTLY TESTED FOR SAFETY AND EFFECTIVENESS THROUGH THE STATUTORY PREMARKET APPROVAL PROCESS, DESPITE BEING PROMOTED AS MAJOR ADVANCES IN STIMULATION TECHNOLOGY.¿ THE ATTORNEY ALLEGED THAT THE MANUFACTURER DID NOT ¿DISCLOSE ANY ISSUES ASSOCIATED WITH THE DEVICE.¿ THE ATTORNEY ALLEGED THAT THE PATIENT¿S INJURIES RESULTED FROM THE ¿LACK OF TRANSPARENCY REGARDING MRI PROCEDURES, AND INTENTIONAL LACK OF COMMUNICATION ONCE THINGS WENT SOUTH.¿ THE ATTORNEY ALLEGED THAT THE MANUFACTURER ¿FAILED TO DISCLOSE THAT THE DEVICE HAD UNDERGONE EXTENSIVE, CUMULATIVE MODIFICATIONS SINCE ITS ORIGINAL APPROVAL UNDER PMA P840001 IN 1984, AND THAT THESE CHANGES WERE IMPLEMENTED WITHOUT NEW CLINICAL TRIALS OR PANEL-TRACK REVIEW. THESE REPRESENTATIONS FAILED TO DISCLOSE SIDE EFFECTS THAT MATERIALLY IMPACTED THE SAFETY AND EFFICACY OF THE DEVICE¿ AND THAT THE MANUFACTURER BREACHED ITS DUTY BY ¿FAILING TO DISCLOSE THAT ITS FIRMWARE MODIFICATIONS, ENERGY DELIVERY PATTERNS, AND DEVICE INTERFACE HAD CONTRIBUTED TO A GROWING NUMBER OF PATIENT COMPLAINTS AND INJURIES¿INCLUDING THOSE INVOLVING BATTERY FAILURE, PAINFUL SHOCKS, STIMULATION LOSS, LEAD MIGRATION, AND LOSS OF EFFICACY.¿ THE ATTORNEY ALLEGED THAT THE INJURIES SUSTAINED BY THE PATIENT WERE THE ¿FORESEEABLE RESULT¿ OF THE MANUFACTURER¿S ¿FAILURE TO COMPLY WITH FEDERAL REGULATORY DUTIES, ITS MISREPRESENTATIONS AND OMISSIONS REGARDING THE SAFETY AND EFFECTIVENESS¿ OF THE INS SYSTEM, AND ITS ¿UNAUTHORIZED PARTICIPATION IN MEDICAL DECISION-MAKING THROUGH UNLICENSED PERSONNEL.¿ THE ATTORNEY ALLEGED THAT THE INS SYSTEM ¿WAS DEFECTIVELY MANUFACTURED¿ AND THAT THE DEVICE DEVIATED FROM ¿DESIGN SPECIFICATIONS AND FROM OTHER UNITS IN THE SAME PRODUCT LINE, RESULTING IN AN UNREASONABLY DANGEROUS CONDITION.¿ THE ATTORNEY ALLEGED THAT ¿THE MANUFACTURING DEFECT INCLUDED, BUT WAS NOT LIMITED TO, IMPROPER ASSEMBLY, DEFECTIVE BATTERY CONTROL FIRMWARE, FLAWED CHARGING TELEMETRY INTEGRATION, AND DEFECTIVE ANCHORING OR LEAD STABILIZATION MECHANISMS¿ AND THAT ¿THESE DEFECTS RENDERED THE DEVICE SUBSTANTIALLY MORE LIKELY TO CAUSE ELECTRICAL SHOCKS, CHARGING FAILURES, LEAD MIGRATION, AND LOSS OF THERAPEUTIC EFFICACY.¿ THE ATTORNEY ALLEGED THAT ¿THE MANUFACTURING DEFECTS DIRECTLY AND PROXIMATELY¿ CAUSED THE PATIENT¿S INJURIES, ¿INCLUDING SEVERE PAIN, WORSENING NEUROLOGIC SYMPTOMS, GASTROPARESIS, RECURRING STAPH BLISTERS, NUMBNESS IN EXT REMITIES, AND DIMINISHED QUALITY OF LIFE.¿ THE ATTORNEY ALLEGED THAT THE INJURIES WERE NOT THE RESULT OF MISUSE OR NEGLIGENCE, BUT THAT THE DEVICE ¿FAILED DURING NORMAL AND FORESEEABLE USE¿ AND AS A DIRECT RESULT OF THE MANUFACTURER¿S ¿MANUFACTURING DEFECT¿ THE PATIENT ¿SUFFERED INJURIES AND DAMAGES INCLUDING PAST AND FUTURE MEDICAL EXPENSES, PAST AND FUTURE PAIN AND SUFFERING, EMOTIONAL DISTRESS, AND LOSS OF ENJOYMENT OF LIFE.¿ THE ATTORNEY ALLEGED THAT THE INS SYSTEM ¿PRESENTED KNOWN OR REASONABLY FORESEEABLE RISKS, INCLUDING BUT NOT LIMITED TO PAINFUL ELECTRICAL SHOCKS, LEAD MIGRATION, PREMATURE BATTERY FAILURE, STIMULATION FAILURE, WORSENING OF PREEXISTING PAIN, AND NEUROLOGIC COMPLICATIONS SUCH AS NUMBNESS IN EXTREMITIES¿ AND THAT ¿THESE RISKS WERE NOT ADEQUATELY DISCLOSED IN THE PRODUCT LABELING, INSTRUCTIONS FOR USE (IFU), TRAINING MATERIALS, OR MARKETING DOCUMENTS PROVIDED TO PHYSICIANS AND PATIENTS.¿ THE PATIENT SUFFERED PHYSICAL INJURIES, PAIN, DIMINISHED THERAPEUTIC BENEFIT, AND PSYCHOLOGICAL DISTRESS THAT ¿WOULD LIKELY HAVE BEEN AVOIDED HAD ADEQUATE WARNINGS BEEN PROVIDED.¿ THE ATTORNEY ALLEGED THAT THE HARMS SUFFERED BY THE PATIENT (CHRONIC PAIN, ELECTRICAL SHOCKS, NEUROLOGIC INJURY, AND LACK OF EFFICACY) WERE ¿THE OF THE KIND THE VIOLATED REGULATIONS WERE DESIGNED TO PREVENT.¿ THE ATTORNEY ALLEGED THAT ADVERSE EVENT REPOTS WERE ¿ACCUMULATING REGARDING THE VERY RISKS CONCEALED FROM LABELING AND TRAINING MATERIALS.¿ THE ATTORNEY ALLEGED THAT THE INS IMPLANTED IN THE PATIENT FAILED TO PERFORM IN ACCORDANCE WITH THE MANUFACTURER¿S ¿EXPRESS WARRANTIES¿ AND THE MANUFACTURER ¿BREACHED ITS EXPRESS WARRANTIES BY SUPPLYING A PRODUCT THAT DID NOT CONFORM TO THE DESCRIPTIONS, AFFIRMA TIONS, AND PROMISES¿ MADE PRIOR TO IMPLANTATION. THE PATIENT SUFFERED INJURIES AND DAMAGES ¿INCLUDING PHYSICAL HARM, MENTAL DISTRESS, DIMINISHED THERAPEUTIC BENEFIT, AND THE NEED FOR FUTURE MEDICAL TREATMENT.¿ THE ATTORNEY ALLEGED THAT THE INS ¿WAS NOT OF MERCHANTABLE QUALITY AND WAS NOT FIT FOR ITS INTENDED OR REPRESENTED PURPOSE¿ AND ¿THE DEVICE FAILED TO DELIVER EFFECTIVE NEUROMODULATION, RESULTED IN PAINFUL SHOCKS¿ WHICH EXACERBATED THE PATIENT¿S UNDERLYING SYMPTOMS AND INTRODUCED NEW COMPLICATIONS INCLUDING URINARY DYSFUNCTION. THE ATTORNEY ALLEGED THAT ¿THESE FAILURES WERE THE DIRECT RESULT OF POST-MARKET MODIFICATIONS MADE TO THE SYSTEM¿PARTICULARLY ITS BATTERY CONTROLLER FIRMWARE, STIMULATION SOFTWARE, AND RECHARGING HARDWARE¿THAT WERE NEITHER TESTED IN NEW CLINICAL TRIALS NOR DISCLOSED¿ TO THE PATIENT OR THEIR PHYSICIAN. THE ATTORNEY ALLEGED THAT ¿THE CUMULATIVE CHANGES TO THE DEVICE ARCHITECTURE AND PROGRAMMING PARAMETERS RENDERED THE IMPLANTED SYSTEM MATERIALLY DIFFERENT FROM ITS ORIGINAL PREDICATE AND MATERIALLY UNFIT FOR ITS REPRESENTED PURPOSE¿ AND THAT THESE CHANGES, ALONG WITH THE MANUFACTURER¿S ¿FAILURE TO DISCLOSE ADVERSE PERFORMANCE DATA, CONSTITUTED A BREACH OF THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS.¿ THE ATTORNEY ALLEGED THAT THE MANUFACTURER DISTRIBUTED INS UNITS ¿WITH BATTERY AND CHARGING DEFECTS LIKELY TO RESULT IN PAIN FLARE-UPS, ELECTRICAL SHOCKS, OR LEAD DYSFUNCTION¿ AND THE MANUFACTURER OMITTED ¿KNOWN RISKS AND COMPLICATIONS FROM PRODUCT LABELING AND TRAINING RESOURCES.¿ THE ATTORNEY ALLEGED THAT THE MANUFACTURER¿S BREACHES OF DUTY WERE A DIRECT AND PROXIMATE CAUSE OF PATIENT'S INJURIES, INCLUDING THEIR "PHYSICAL PAIN, NEUROLOGICAL DECLINE, LOSS OF THERAPEUTIC BENEFIT, EMOTIONAL DISTRESS, AND THE NEED FOR CONTINUING MEDICAL CARE.¿ THE ATTORNEY ALLEGED THAT AS A DIRECT AND PROXIMATE RESULT OF THE MANUFACTURER¿S ¿VIOLATIONS OF THESE STATUTORY DUTIES¿ THE PATIENT ¿SUFFERED PHYSICAL INJURIES, LOSS OF THERAPEUTIC BENEFIT, AND EMOTIONAL DISTRESS CAUSED BY IMPROPER DEVICE PROGRAMMING, INADEQUATE POSTOPERATIVE SUPPORT, AND A LACK OF INFORMED MEDICAL DECISION-MAKING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245529 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Disability "SEE H11."