BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3793400 · Received May 6, 2014

    Report

    Report Number
    3007566237-2014-01252
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    February 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. 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. CONCOMITANT PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    LEWIS, C.J., MAIER, F., EGGERS, C., PELZER, E.A., MAAROUF, M., MORO, E., ZUROWSKI, M., KUHN, J., WOOPEN, C., TIMMERMANN, L. PARKINSON'S DISEASE PATIENTS WITH SUBTHALAMIC STIMULATION AND CARERS JUDGE QUALITY OF LIFE DIFFERENTLY. PARKINSONISM AND RELATED DISORDERS. 1353;2014: 1-6. HTTP://DX.DOI.ORG/10.1016/J.PARKRELDIS.2014.02.009. SUMMARY: QUALITY OF LIFE (QOL) IMPROVES UNDER SUBTHALAMIC DEEP BRAIN STIMULATION (STN-DBS) IN PARKINSON¿S DISEASE (PD), WHEREAS SOCIAL FUNCTIONING MAY BE DISRUPTED. THIS DISRUPTION COULD NEGATIVELY INFLUENCE THE FAMILY DYNAMIC, LEADING TO DIFFERENT PERCEPTIONS OF THE STN-DBS OUTCOME BY PATIENTS AND CAREGIVERS. WE RECRUITED 34 PD PATIENTS FOR THIS PROSPECTIVE, CONTROLLED TRIAL, 28 OF WHOM WERE EXAMINED PREOPERATIVELY, THREE MONTHS AND ONE YEAR AFTER STN-DBS SURGERY. THE PRIMARY OUTCOME WAS QOL. WE COMPARED THE PATIENTS¿ RATINGS AND CAREGIVERS¿ PROXY QOL RATINGS. THE SECONDARY OUTCOME WAS SOCIAL FUNCTIONING. ADDITIONALLY, NEUROLOGICAL, NEUROPSYCHIATRIC AND COGNITIVE DOMAINS WERE ANALYZED. CHANGES WERE ANALYZED WITH REPEATED-MEASURES ANOVA. REGRESSION ANALYSIS WAS USED TO DETERMINE THE ASSOCIATION BETWEEN QOL AND SOCIAL FUNCTIONING. PATIENTS¿ QOL IMPROVED SIGNIFICANTLY UNDER STN-DBS (P ¼ .003). AT BASELINE, PATIENTS¿ AND CAREGIVERS¿ QOL RATINGS WERE SIMILAR. HOWEVER, ONE YEAR POSTOPERATIVELY, QOL RATINGS DIFFERED SIGNIFICANTLY (P ¼ .010), WHEREBY QOL WAS RATED WORSE BY CAREGIVERS. SOCIAL FUNCTIONING WAS POSITIVELY INFLUENCED DURING THE FIRST MONTHS POSTOPERATIVELY, BUT DID NOT IMPROVE LONGITUDINALLY. ONE YEAR POSTOPERATIVELY, SOCIALFUNCTIONING WAS SIGNIFICANTLY ASSOCIATED WITH QOL RATINGS (PATIENT S: P ¼ .004, CAREGIVERS: P ¼ .002). MOTOR SCORES SIGNIFICANTLY IMPROVED, WHEREAS VERBAL FLUENCY AND APATHY WORSENED. UNEQUAL PERCEPTION OF QOL BETWEEN PATIENTS AND CAREGIVERS EXISTS UNDER STN-DBS. THE FACT THAT SOCIAL FUNCTIONING DOES NOT IMPROVE LONGITUDINALLY IS PERHAPS DUE TO PATIENT¿S HIGHER LEVELS OF APATHY AND REDUCED MOTIVATION FOLLOWING SURGERY. OUR FINDINGS STRESS THE IMPORTANCE OF CONSIDERING CAREGIVER¿S INPUT IN DBS PATIENTS¿ OUTCOMES AND THE NEED FOR PRE-OPERATIVE PREPARATION. REPORTED EVENTS: 1. 1 PATIENT EXPERIENCED A STIMULATION RELATED DEPRESSIVE EPISODE WITH RISK OF SUICIDE. IT WAS NOTED THAT THIS RESOLVED UNDER TREATMENT. 2. 1 PATIENT EXPERIENCED AN INFECTION FOLLOWING SURGERY WHICH RESULTED IN REMOVAL OF THE LEADS. 3. 4 PATIENTS EXPERIENCED SURGERY RELATED ELEVATED INFECTION PARAMETERS WITHOUT CLINICAL EVIDENCE. IT WAS NOTED THAT THESE RESOLVED. THE SOURCE LITERATURE DID NOT INCLUDE ANY DEVICE SPECIFICS. 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
    270249 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Life Threatening| R