BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 24970958 · Received April 23, 2026

    Report

    Report Number
    3004209178-2026-07102
    Event Type
    Injury
    Date Received
    April 23, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NEU_LABEL_ACC, 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 A LEGAL REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE ATTORNEY BROUGHT STATE-LAW CLAIMS AGAINST THE MANUFACTURER FOR PERSONAL INJURIES SUSTAINED ¿AS A RESULT OF ITS DEFECTIVE SPINAL CORD STIMULATOR DEVICE.¿ THE ATTORNEY INITIALLY ALLEGED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2020, HOWEVER, THEY LATER REPORTED THE PATIENT WAS IMPLANTED ON (B)(6) 2022. THE ATTORNEY NOTED THAT THE INS IMPLANTED IN THE PATIENT ¿WAS APPROVED UNDER PMA P840001 AND 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 INS ¿INCLUDE 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 POST-APPROVAL MODIFICATIONS TO THE INS ¿MATERIALLY ALTERED THE SAFETY AND FUNCTIONALITY PROFILE OF THE SYSTEM BUT WERE NOT DISCLOSED TO PHYSICIANS OR PATIENTS.¿ THE ATTORNEY ALLEGED THAT THE CUMULATIVE CHANGES WHICH SPANNED ¿HARDWARE DESIGN, SOFTWARE CONTROL, STIMULATION DELIVERY, ENERGY SOURCE, AND INTERFACE PROTOCOLS, MATERIALLY ALTERED THE MECHANISM OF ACTION, CLINICAL HANDLING, AND RISK PROFILE¿ OF THE SPINAL CORD STIMULATION SYSTEM. THE ATTORNEY ALLEGED THAT THE INS ¿MATERIALLY ALTERED FROM ITS ORIGINAL APPROVED FORM.¿ AFTER CONSERVATIVE THERAPIES FAILED TO CONTROL THE PATIENT¿S PAIN, THEY UNDERWENT A SPINAL CORD STIMULATOR TRIAL, WHICH WAS DEEMED SUCCESSFUL ACCORDING TO THE IMPLANTING PHYSICIAN. THE ATTORNEY ALLEGED THAT THE INS WAS 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.¿ COMPLICATIONS AND PROGRESSIVE INJURIES MARKED THE PATIENT¿S POST-IMPLANTATION COURSE. THEY EXPERIENCED PERSISTENT AND WORSENING PAIN AT AND AROUND THE INS SITE, INCONTINENCE, LOWER EXTREMITY WEAKNESS REQUIRING ASSISTIVE DEVICES FOR AMBULATION, AND EPISODES OF UNINTENDED STIMULATION AND SHOCKING SENSATIONS. OVER TIME, THE PATIENT ALSO DEVELOPED WORSENING PAIN IN AREAS NOT TARGETED BY THE THERAPY, AS WELL AS DISCOMFORT THAT THE PATIENT AND THEIR HEALTHCARE PROVIDERS COULD NOT INITIALLY ATTRIBUTE TO A SPECIFIC DEVICE MALFUNCTION. IN ONE INTERACTION SHORTLY BEFORE THEIR DEVICE WAS ¿EXPLANTED,¿ THE PATIENT TOLD A MANUFACTURER SALES REPRESENTATIVE THAT THE DEVICE WAS OVERSTIMULATING THEIR LOWER EXTREMITIES AND WAS CAUSING UNCONTROLLABLE SHAKING IN THEIR LEGS, AND THE REPRESENTATIVE INDICATED THAT THE PATIENT WAS SIMPLY GETTING ACCUSTOMED TO THE THERAPY. THE ATTORNEY ALLEGED THAT WHEN THE PATIENT REPORTED A NEGATIVE EXPERIENCE TO A REPRESENTATIVE, THEIR COMPLAINT WAS MET WITH THE RESPONSE ¿JUST GIVE IT MORE TIME.¿ THE ATTORNEY ALLEGED THAT THE PATIENT¿S ¿INJURIES RESULTED FROM THE IMPLANTATION AND USE OF THE ADULTERATED DEVICE¿ AND THE MANUFACTURER¿S ¿WRONGFUL ACTIONS.¿ THE ATTORNEY ALLEGED THAT THE MANUFACTURER¿S ¿MARKETING MATERIALS, TRAINING PRESENTATIONS, SALES REPRESENTATIVE SCRIPTS, AND LABELING MATERIALS DID NOT DISCLOSE¿ THAT THE INS SYSTEM ¿WAS BASED ON POST-2017 MODIFICATIONS THAT MATERIALLY ALTERED THE DEVICE¿S DESIGN, FIRMWARE, CHARGING INTERFACE, AND PATIENT-CONTROL ALGORITHMS.¿ 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 IMPLANTED IN THE PATIENT ¿WAS DEFECTIVELY MANUFACTURED¿ AND THAT ¿THE DEVICE, AS CONSTRUCTED AND ASSEMBLED, DEVIATED¿ FROM THE MANUFACTURER¿S ¿DESIGN SPECIFICATIONS AND FROM OTHER UNITS IN THE SAME PRODUCT LINE, RESULTING IN AN UNREASONABLY DANGEROUS CONDITION¿ AT THE TIME IT LEFT THE MANUFACTURER¿S CONTROL. 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, URINARY INCONTINENCE, AND DIMINISHED QUALITY OF LIFE¿ AND THE PATIENT SUFFERED ¿INJURIES AND DAMAGES INCLUDING PAST AND FUTURE MEDICAL EXPENSES, PAIN AND SUFFERING, EMOTIONAL DISTRESS, AND LOSS OF ENJOYMENT OF LIFE.¿ THE PATIENT ¿SUFFERED PHYSICAL INJURIES, PAIN, DIMINISHED THERAPEUTIC BENEFIT, AND PSYCHOLOGICAL DISTRESS THAT WOULD LIKELY HAVE BEEN AVOIDED HAD ADEQUATE WARNINGS BEEN PROVIDED.¿ THE PATIENT EXPERIENCED MENTAL ANGUISH. THE ATTORNEY ALLEGED THAT THE DEVICE FAILED DURING NORMAL AND FORESEEABLE USE. 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 URINARY INCONTINENCE¿ 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 ATTORNEY ALLEGED THAT THE MANUFACTURER ¿FAILED TO DISCLOSE TO PHYSICIANS OR THE PUBLIC¿ THAT THE INS SYSTEM ¿HAD BEEN APPROVED VIA SUCCESSIVE SUPPLEMENTS TO PMA P840001 WITHOUT PANEL-TRACK REVIEW, WITHOUT CLINICAL TESTING OF THE REVISED CONFIGURATIONS, AND WITHOUT UPDATED LABELING REFLECTING DEVICE EVOLUTION AND NEW FAILURE MODES.¿ THE ATTORNEY ALLEGED THAT THE PATIENT ¿RECEIVED A DEVICE WHOSE ACTUAL RISKS FAR EXCEEDED THOSE DISCLOSED AT THE TIME OF IMPLANTATION.¿ THE ATTORNEY ALLEGED THAT THE PATIENT¿S INJURIES ¿WERE THE FORESEEABLE RESULT¿ OF THE MANUFACTURER¿S ¿FAILURE TO COMPLY WITH THESE BINDING REGULATORY REQUIREMENTS¿ AND THAT THE HARMS SUFFERED BY THE PATIENT (CHRONIC PAIN, ELECTRICAL SHOCKS, NEUROLOGIC INJURY, AND LACK OF EFFICACY) WERE ¿THE KIND THE VIOLATED REGULATIONS WERE DESIGNED TO PREVENT.¿ THE ATTORNEY ALLEGED THAT THE MANUFACTURER FAILED TO DISCLOSE THAT THE INS SYSTEM ¿HAD UNDERGONE SIGNIFICANT POST-MARKET MODIFICATIONS UNDER PMA P840001, THAT THOSE MODIFICATIONS HAD NOT BEEN VALIDATED THROUGH CLINICAL TRIALS, AND THAT ADVERSE EVENT REPORTS WERE ACCUMULATING REGARDING THE VERY RISKS CONCEALED FROM LABELING AND T RAINING MATERIALS.¿ THE INS FAILED TO PERFORM IN ACCORDANCE WITH THE MANUFACTURER¿S EXPRESS WARRANTIES AND THAT ¿RATHER THAN DELIVERING SAFE AND EFFECTIVE NEUROMODULATION THERAPY, THE DEVICE CAUSED ELECTRIC SHOCKS, PAIN AGGRAVATION, AND NEW-ONSET NEUROLOGIC DYSFUN CTION.¿ THE ATTORNEY ALLEGED THAT THE INS SYSTEM WAS ¿NOT OF MERCHANTABLE QUALITY¿ AND IT WAS NOT ¿FIT FOR ITS INTENDED OR REPRESENTED PURPOSE.¿ THE DEVICE FAILED TO DELIVER EFFECTIVE NEUROMODULATION, RESULTED IN PAINFUL SHOCKS, 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 MANUFACTURER MANUFACTURED AND DISTRIBUTED INS UNITS ¿WITH BATTERY AND CHARGING DEFECTS LIKELY TO RESULT IN PAIN FLARE-UPS, ELECTRICAL SHOCKS, OR LEAD DYSFUNCTION¿ AND THAT THE MANUFACTURER OMITTED ¿KNOWN RISKS AND COMPLICATIONS FROM PRODUCT LABELING AND TRAINING RESOURCES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382093 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

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