BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5979805 · Received September 27, 2016

    Report

    Report Number
    3007566237-2016-03378
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    March 8, 2016
    Report Date
    September 27, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3387, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SILVA, D., MATIAS, C., BOURNE, S., NAGEL, S., MACHADO, A., LOBEL, D. EFFECTS OF CHRONIC ALCOHOL CONSUMPTION ON LONG-TERM OUTCOMES OF THALAMIC DEEP BRAIN STIMULATION FOR ESSENTIAL TREMOR. JOURNAL OF CLINICAL NEUROSCIENCE : OFFICIAL JOURNAL OF THE NEUROSURGICAL SOCIETY OF AUSTRALASIA. 2016. 31:142-146. SUMMARY: THE PREVALENCE OF ESSENTIAL TREMOR (ET) IS ABOUT 4% ABOVE 40 YEARS OF AGE. CHRONIC ALCOHOL CONSUMPTION IS PRESENT IN AROUND 20% OF PATIENTS WITH ET. OUR OBJECTIVE WAS TO IDENTIFY WHETHER CHRONIC ALCOHOL CONSUMPTION WAS ASSOCIATED WITH A NEGATIVE EFFECT ON TREMOR OUTCOME AFTER THALAMIC DEEP BRAIN STIMULATION (DBS) IN ET PATIENTS. REPORTED EVENTS: 1 PATIENT WITH VENTRAL INTERMEDIATE NUCLEUS (VIM) DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR (ET) WITHOUT A HISTORY OF CHRONIC ALCOHOL CONSUMPTION EXPERIENCED AN IMPLANTABLE NEUROSTIMULATOR (INS) SITE INFECTION AS A COMPLICATION OF SURGERY. THE GENERATOR AND EXTENSION WIRE HAD TO BE REMOVED AND RE-IMPLANTED AFTER THE INFECTION WAS CLEARED WITH ANTIBIOTICS. ONE PATIENT WITH VIM DBS FOR ET WITH A HISTORY OF CHRONIC ALCOHOL CONSUMPTION DEVELOPED INTRACEREBRAL HEMORRHAGE AS A COMPLICATION OF SURGERY. THIS RESULTED IN PERSISTENT HEMIPARESIS, URINARY INCONTINENCE, AND WORSENING COGNITION. TWO PATIENTS WITH VIM DBS FOR ET WITHOUT A HISTORY OF CHRONIC ALCOHOL CONSUMPTION EXPERIENCED POSTOPERATIVE INTRACEREBRAL HEMORRHAGE AS A COMPLICATION OF SURGERY THAT RESULTED IN MILD HEMIPARESIS THAT IMPROVED OVER TIME. ONE PATIENT WITH VIM DBS FOR ET WITH A HISTORY OF CHRONIC ALCOHOL CONSUMPTION DEVELOPED DEEP VENOUS THROMBOSIS THAT WAS TREATED WITH AN INFERIOR VENA CAVA FILTER. THIS WAS CONSIDERED A CLINICAL COMPLICATION. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631355 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R