BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 5661218 · Received May 17, 2016

    Report

    Report Number
    3007566237-2016-02023
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    November 9, 2005
    Report Date
    May 17, 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

    EVENT DATE: 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. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD.

    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 STIMULATORS (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 1: A (B)(6) WOMAN WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) FOR MYOCLONIC DYSTONIA EXPERIENCED FRACTURE AND MIGRATION OF THE LEFT ELECTRODE 15 MONTHS POST-IMPLANT. THIS REQUIRED AN ADDITIONAL SURGERY, WHICH WAS SUCCESSFULLY CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315965 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention