BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 13763358 · Received March 14, 2022

    Report

    Report Number
    2182207-2022-00414
    Event Type
    Injury
    Date Received
    March 14, 2022
    Report Date
    May 19, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: REIZINHO C, SANTOS A, BARATA A, LUIS A, CAETANO A, MENDONCA M, CUNHA L, JESUS C, FERREIRA N, ANTONIA C. PROGRESSIVE AND LATE ONSET LIFETHREATENING ADVERSE EFFECT OF SPINAL CORD STIMULATION FOR CHRONIC PAIN TREATMENT. STEREOTACT FUNCT NEUROSURG 2021; 99 (SUPPL 1): 129. DOI: 10.1159/000520618. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    (B)(6)-YEAR-OLD WOMAN, WITH FAILED-BACK SURGERY SYNDROME WAS SUBMITTED TO DORSAL EPIDURAL PLACEMENT OF A SURGICAL 16-CONTACT PLATE ELECTRODE IN D8-D9 LEVEL AND A RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS). THE BEST EFFECT ON PAIN (NRS-0) WAS ATTAINED WITH CYCLIC PROGRAMMING (+1,-5 ACTIVE CONTACTS, PULSE WIDTH-300S, FREQUENCY-60 HZ, AMPLITUDE-3, 5 MA). AT 8-9 WEEKS POST-OP, A REVERSIBLE AND DEPENDENT ON STIMULATION (RDS) HIGH FREQUENCY RIGHT LOWER LIMB TREMOR DEVELOPED AND PROGRESSIVELY INCREASED IN INTENSITY. RDS URINARY INCONTINENCE DEVELOPED 8 MONTHS POST-OP. AT 9 MONTHS POST-OP TREMOR BECAME GENERALIZED AND IMPOSSIBLE TO TOLERATE, AND RDS SEVERE HYPERTENSION (OVER 200 MMHG SYSTOLIC PRESSURE) AND TACHYCARDIA (OVER 150 BPM) DEVELOPED AND LEAD TO SYNCOPE. THE PATIENT WAS ADMITTED AT 11 MONTHS POST-OP AND MONITORED WITH ELECTROMYOGRAPHY AND INTRA-ARTERIAL INVASIVE PRESSURE MONITORING. THERE WAS A DIRECT CORRELATION BETWEEN SCS ACTIVE PERIODS AND DEVELOPMENT OF GENERALIZED MOTOR ACTIVITY COMPATIBLE WITH CRAMP/SPASM, URINARY INCONTINENCE, TACHYCARDIA AND SEVERE HYPERTENSION. ELECTRODE POSITIONING WAS CONFIRMED ON CT. THE PATIENT WAS RESTARTED ON MORPHINE AND THE STIMULATOR WAS PUT IN OFF MODE PERMANENTLY.

    Description of Event or Problem · 0

    ADDITIONAL REVIEW FOUND THAT THE EVENT CAPTURED IN THIS REPORT HAS BEEN PREVIOUSLY REPORTED BY THE MANUFACTURER THROUGH REGULATORY REPORT #3004209178-2019-08510. PLEASE SEE REGULATORY REPORT #3004209178-2019-08510 FOR ANY FUTURE UPDATES REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292976 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97715 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization