BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3155401 · Received June 8, 2013

    Report

    Report Number
    3007566237-2013-01892
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4). DEVICE USED FOR ANOREXIA NERVOSA.

    Description of Event or Problem · 1

    LIPSMAN, N., WOODSIDE, D. B., GIACOBBE, P., HAMANI, C., CARTER, J. C., NORWOOD, S. J., SUTANDAR, K., STAAB, R., ELIAS, G., LYMAN, C. H., SMITH, G. S., LOZANO, A. M. SUBCALLOSAL CINGULATE DEEP BRAIN STIMULATION FOR TREATMENT-REFRACTORY ANOREXIA NERVOSA: A PHASE 1 PILOT TRIAL. LANCET. 2013;381(9875):1361-1370. DOI: 10.1016/S0140-6736(12)62188-6. SUMMARY: SIX WOMEN WITH INTRACTABLE AND LIFE THREATENING ANOREXIA NERVOSA HAVE BEEN TREATED WITH DEEP BRAIN STIMULATION IN A PRELIMINARY STUDY FROM TORONTO, CANADA. DOCTORS SELECTED THE WOMEN FOR DEEP BRAIN STIMULATION AFTER MANY YEARS OF UNSUCCESSFUL CONVENTIONAL MANAGEMENT. THEY HAD AVERAGE BODY MASS INDICES (BMIS) OF 11 TO 15 IN THE YEARS LEADING UP TO THE STUDY, ACCOMPANIED BY MULTIPLE MEDICAL COMPLICATIONS OF CHRONIC STARVATION. FIVE HAD PSYCHIATRIC COMORBIDITIES, MOST OFTEN MAJOR DEPRESSION AND OBSESSIVE COMPULSIVE DISORDER. REPORTED EVENT: A PATIENT HAD A CARDIAC AIR EMBOLUS THAT RESOLVED WITHIN 5 MINUTES AFTER REPOSITIONING OF THE OPERATING TABLE. 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
    257757 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other