BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6446085 · Received March 30, 2017

    Report

    Report Number
    3007566237-2017-01203
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    March 7, 2013
    Report Date
    March 30, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PLEASE NOTE THIS DATE IS BASED OFF THE PUBLICATION DATE OF THE ARTICLE, AS SPECIFIC EVENT DATE WAS NOT PROVIDED. DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS ANOREXIA.

    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 INCREASED LEAD IMPEDANCE. AFTER 2 MONTHS, THE PATIENT HAD LOST WEIGHT FROM THEIR PREOPERATIVE BODY MASS INDEX (BMI). DEVICE HAD NO APPARENT EFFECT, POSITIVE OR NEGATIVE, ON PATIENT¿S WEIGHT BY THE END OF THE TRIAL. IT WAS NOTED THAT THERE WERE NO CHANGES IN BMI AT 9 MONTHS, BUT DID SEE SOME IMPROVEMENTS IN MOOD OR OBSESSION AND COMPULSION SCORES AT 6 MONTHS. NO COMPLICATIONS OR FURTHER COMPLICATIONS WERE REPORTED. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230097 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR