BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

    MDR report key: 5663204 · Received May 18, 2016

    Report

    Report Number
    3007566237-2016-02032
    Event Type
    Injury
    Date Received
    May 18, 2016
    Date of Event
    November 9, 2005
    Report Date
    June 15, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL REVIEW OF THE REPORTED EVENT DETAILS CONCLUDED THAT THE REPORTED INTRAUTERINE GROWTH RETARDATION AND REDUCED FETAL MOVEMENT, RESULTING IN PREMATURE INDUCEMENT OF LABOR IN THE (B)(6) WEEK OF PREGNANCY WAS NOT RELATED TO THE DEVICE OR THERAPY BASED ON THE AUTHORS¿ CONCLUSIONS THAT A CAUSAL RELATIONSHIP IS UNLIKELY. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PALUZZI, A., BAIN, P.G., LIU, X., YIANNI, J., KUMARENDRAN, K., AZIZ, T.Z. PREGNANCY IN DYSTONIC WOMEN WITH IN SITU DEEP BRAIN STIMULATORS. MOVEMENT DISORDERS. 2006. 21:5(695-698). DOI: 10.1002/MDS.20777 SUMMARY: IN THE PAST FEW YEARS, AN INCREASING NUMBER OF DYSTONIC PATIENTS, OF BOTH SEXES, HAVE UNDERGONE INSERTION OF DEEP BRAIN S TIMULATORS (DBS) WITH CONSISTENT IMPROVEMENT OF THEIR SYMPTOMS AND ENHANCEMENT OF THEIR QUALITY OF LIFE. WE DESCRIBE 3 WOMEN WITH DYSTONIA WHO, AFTER INSERTION OF BILATERAL GLOBUS PALLIDUS INTERNUS STIMULATORS, SUCCEEDED IN CONCEIVING AND COMPLETING PREGNANCIES, 2 OF THEM HAVING MARRIED. THESE HISTORIES ILLUSTRATE THE SIGNIFICANT POSITIVE IMPACT THAT DBS CAN HAVE ON WOMEN'S SOCIAL RELATIONSHIPS. BASED ON THIS EXPERIENCE, WE ALSO PROVIDE AN OVERVIEW OF SOME OF THE ISSUES THAT MIGHT ARISE IN PREGNANCY AND DURING DELIVERY IN DYSTONIC WOMEN WITH AN IN SITU DEEP BRAIN STIMULATOR. REPORTED EVENTS: PATIENT 3: A (B)(6)YEAR-OLD WOMAN WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) FOR GENERALIZED DYSTONIA HAD TO BE ADMITTED TO THE HOSPITAL AS AN EMERGENCY (HAVING JUST ENTERED THE THIRD TRIMESTER OF PREGNANCY) IN STATUS DYSTONICUS BECAUSE THE PACEMAKER BATTERIES HAD EXPIRED (19 MONTHS AFTER IMPLANTATION). THE PACEMAKER BOX WAS REPLACED UNDER GENERAL ANESTHETIC WITHOUT ANY COMPLICATIONS, AND ONCE AGAIN HER DYSTONIA IMPROVED. LABOR WAS INDUCED IN THE HOSPITAL WITH PROSTAGLANDINS IN THE (B)(6) WEEK BECAUSE OF INTRAUTERINE GROWTH RETARDATION AND REDUCED FETAL MOVEMENT, AND SHE UNDERWENT AN UNCOMPLICATED VAGINAL DELIVERY OF A HEALTHY BOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317886 IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R