BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3849410 · Received June 4, 2014

    Report

    Report Number
    3007566237-2014-01527
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED 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. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE DEVICE WAS USED TO TREAT PAIN. CONCOMITANT PRODUCTS: PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    BOCCARD, S.G., FITZGERALD, J.J., PEREIRA, E.A., MOIR, L., HARTEVELT, T.J.V., KRINGELBACH, M.L., GREEN, A.L., AZIZ, T.Z. TARGETING THE AFFECTIVE COMPONENT OF CHRONIC PAIN: A CASE SERIES OF DEEP BRAIN STIMULATION OF THE ANTERIOR CINGULATE CORTEX. NEUROSURGERY. 2014. DOI: 10.1227/NEU.0000000000000321 SUMMARY: DEEP BRAIN STIMULATION (DBS) HAS SHOWN CONSIDERABLE PROMISE FOR RELIEVING NOCICEPTIVE AND NEUROPATHIC SYMPTOMS OF REFRACTORY CHRONIC PAIN. NEVERTHELESS, FOR SOME PATIENTS, STANDARD DBS FOR PAIN REMAINS POORLY EFFICACIOUS. PAIN IS A MULTI-DIMENSIONAL EXPERIENCE WITH AN AFFECTIVE COMPONENT: THE UNPLEASANTNESS. THE ANTERIOR CINGULATE CORTEX (ACC) IS A STRUCTURE INVOLVED IN THIS AFFECTIVE COMPONENT AND TARGETING IT MAY RELIEVE PATIENTS. TO DESCRIBE THE FIRST CASE SERIES OF ACC DBS TO RELIEVE THE AFFECTIVE COMPONENT OF CHRONIC NEUROPATHIC PAIN. SIXTEEN PATIENTS (13 MALES AND 3 FEMALES) WITH NEUROPATHIC PAIN UNDERWENT BILATERAL ACC DBS. MEAN AGE AT SURGERY WAS 48.7 [33-63] YEARS. PATIENT REPORTED OUTCOME MEASURES WERE COLLECTED BEFORE AND AFTER SURGERY, USING A VISUAL ANALOGUE SCALE (VAS), SHORT FORM 36 QUALITY OF LIFE SURVEY (SF-36), MCGILL PAIN QUESTIONNAIRE (MPQ) AND EUROQOL-5D QUESTIONNAIRES (EQ-5D; HEALTH STATE). 15 PATIENTS (93.3 %) TRANSITIONED FROM EXTERNALIZED TO FULLY INTERNALIZED SYSTEMS. 11 PATIENTS HAD DATA TO BE ANALYZED WITH A MEAN FOLLOW-UP OF 13.2 MONTHS. POST-SURGERY, VAS DROPPED BELOW 4 FOR 5 OF THE PATIENTS, WITH ONE PATIENT FREED FROM PAIN. HIGHLY SIGNIFICANT IMPROVEMENT OF EQ-5D WAS OBSERVED (MEAN +20.3%, RANGE +0% TO +83%, P=0.008). MOREOVER, STATISTICALLY SIGNIFICANT IMPROVEMENTS WERE OBSERVED FOR THE PF (PHYSICAL FUNCTIONING) AND BP (BODILY PAIN) DOMAINS OF THE SF-36 QUALITY OF LIFE SURVEY: MEAN +64.7% (RANGE -8.9% TO +276%, P=0.015) AND MEAN +39.0% (RANGE -33.8% TO +159%, P=0.050), RESPECTIVELY. AFFECTIVE ACC DBS CAN RELIEVE CHRONIC NEUROPATHIC PAIN REFRACTORY TO PHARMACOTHERAPY AND RESTORE QUALITY OF LIFE. REPORTED EVENTS: ONE 51-YEAR-OLD MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR FAILED BACK SURGERY SYNDROME (FBSS) HAD THE RIGHT WIRE BREAK. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325883 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR