BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 6214117 · Received December 29, 2016

    Report

    Report Number
    3007566237-2016-04590
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    January 1, 2010
    Report Date
    December 29, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THE EVENT DATE IS ONLY MONTH AND YEAR VALID. 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3587A, PRODUCT TYPE: LEAD. PRODUCT ID 3587A, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VOIRIN, J., DARIE, I., FISCHER, D., SIMON, A., ROHMER-HEITZ, I., PROUST, F. ZICONOTIDE INTRATHECAL DELIVERY AS TREATMENT FOR SECONDARY THERAPEUTIC FAILURE OF MOTOR CORTEX STIMULATION AFTER 6 YEARS. NEURO-CHIRURGIE. 2016. 62: 284-288. DOI: 10.1016/J.NEUCHI.2016.06.007. SUMMARY: THE PATIENT PRESENTED WITH NEUROPATHIC PAIN IN HIS RIGHT ARM DUE TO A CERVICAL SYRINX WHICH WAS SURGICALLY TREATED BY A SHUNT IN 2003 WITH NO CLINICAL IMPROVEMENT. AS ALTERNATIVE THERAPY,AFTER AN EVALUATION BY REPETITIVE MAGNETIC TRANSCRANIAL STIMULATION WITH SIGNIFICANT BENEFIT, MOTOR CORTEX STIMULATION WAS SUCCESSFULLY IMPLANTED IN 2004. IN 2010, A SIMILAR PAIN OCCURRED IN THE SAME TERRITORY. LOCAL MEAN PAIN VISUAL ANALOGICAL SCALE (VAS) INCREASED TO 82/100. A NEWER GENERATION STIMULATION DEVICE WAS THEN IMPLANTED AND, WITHIN A PERIOD OF 8 MONTHS, DIFFERENT STIMULATION PARAMETER SETTINGS WERE TESTED, WITHOUT ANY PAIN RELIEF. AN INTRATHECAL DRUG DELIVERY PUMP WAS THEN IMPLANTED IN 2011, AND THE UPPER EXTREMITY CATHETER WAS LOCATED AT THE CERVICO-THORACIC JUNCTION. THERE WAS NO POSTOPERATIVE COMPLICATION. A BITHERAPY WAS INITIATED AT A DAILY DOSAGE OF 0.2 MG MORPHINE AND 1.3 UG ZICONOTIDE, NOT MODIFIED SINCE (B)(6) 2013. AT 43 MONTHS FOLLOW-UP, MEAN VAS WAS 21/100 WITH IMPROVEMENT OF DAILY LIFE AND SPARE-TIME ACTIVITIES, ANXIETY AND DEPRESSION, QUALITY OF LIFE (AS MEASURED BY THE SF-36 SURVEY AND EQ-5D-3L QUESTIONNAIRE). REPORTED EVENT: IT WAS REPORTED A (B)(6) MALE PATIENT REPORTED A DECREASE IN PAINKILLER EFFECT FROM THEIR MOTOR CORTEX STIMULATOR (MCS) SYSTEM IN (B)(6) 2010, SIX YEARS AFTER INITIAL IMPLANT. THE PATIENT HAD ORIGINALLY PRESENTED WITH NEUROPATHIC PAIN IN HIS RIGHT UPPER ARM DUE TO A CERVICAL SYRINX WHICH WAS SURGICALLY TREATED BY A SHUNT IN 2003 WITH NO CLINICAL IMPROVEMENT. AS AN ALTERNATIVE THERAPY, AFTER AN EVALUATION BY REPETITIVE MAGNETIC TRANSCRANIAL STIMULATION (RTMS) WITH SIGNIFICANT BENEFIT, A MCS WAS SUCCESSFULLY IMPLANTED IN 2004. THE PATIENT EXPERIENCED A SIGNIFICANT PAINKILLER EFFECT FROM THE SYSTEM THAT HAD LASTED FOR SIX YEARS, WITH STABLE PAIN CONTROL AND NO FLUCTUATION. HOWEVER IN (B)(6) 2010, AN IDENTICAL PAIN GRADUALLY RECURRED DURING A TWO-WEEK PERIOD. THE NEUROPATHIC PAIN COMPONENT WAS ASSESSED BY DN4 QUESTIONNAIRE WITH A LEVEL OF 8/10. THE PATIENT¿S LOCAL MEAN PAIN VISUAL ANALOGICAL SCALE (VAS) SCORE INCREASED TO 82/100. IT WAS STATED THE PATIENT¿S ¿NEUROMODULATION FAILED AFTER A PERIOD OF 6 YEARS OF EFFICACY¿ WITH A ¿PROGRESSIVE DECREASE OF PAINKILLER EFFECT.¿ ON THE PATIENT¿S RETURN TO THEIR CLINIC IN (B)(6) 2010, SEVERAL MCS PARAMETER MODIFICATIONS WERE PERFORMED UNSUCCESSFULLY, OVER AN 8-MONTH PERIOD. IMPEDANCE TESTING WAS PERFORMED AND FOUND THAT ALL SYSTEM IMPEDANCES (INCLUDING THERAPY IMPEDANCES AND UNIPOLAR IMPEDANCES) WERE WITHIN THE NORMAL RANGE. A CEREBRAL CT SCAN DID NOT SHOW ANY ELECTRODE MIGRATION OR DISCONNECTION. THE PATIENT¿S MCS HAD ¿BECOME NO LONGER EFFECTIVE ENOUGH.¿ AS A RESULT, ¿A POSSIBLE BATTERY FAILURE WAS SUSPECTED.¿ THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED IN (B)(6) 2011 AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862439 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention