BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3773782 · Received April 25, 2014

    Report

    Report Number
    3007566237-2014-01155
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    December 12, 2013
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    GURIDI, J.. COMMENTARY. MOVEMENT DISORDERS : OFFICIAL JOURNAL OF THE MOVEMENT DISORDER SOCIETY. 2014;29(2):190. DOI: 10.1002/MDS.25811 SUMMARY: THIS CLINICAL VIGNETTE DESCRIBES A YOUNG DYT-1 DYSTONIC PATIENT TREATED WITH BILATERAL PALLIDAL STIMULATION WHO AFTER UNILATERAL BATTERY DEPLETION WENT ON TO DEVELOP A DYSTONIC STORM LEADING TO RESPIRATORY FAILURE, WHICH REQUIRED SEDATION AND TRACHEAL INTUBATION. REPORTED EVENT: ONE DYSTONIC PATIENT, TREATED WITH BILATERAL PALLIDAL STIMULATION, DEVELOPED A DYSTONIC STORM LEADING TO RESPIRATORY FAILURE, WHICH REQUIRED SEDATION AND TRACHEAL INTUBATION FOLLOWING UNILATERAL BATTERY DEPLETION. THE REPORTER STATED THAT THE DEPLETED IMPLANTABLE NEUROSTIMULATOR (INS) WAS RESTORED 24 HOURS AFTER HOSPITAL ADMISSION AND WAS PROGRAMMED IMMEDIATELY AFTER SURGERY WITH THE PREVIOUS STIMULATION PARAMETERS. IT WAS NOTED THAT WHILE IMPROVEMENT TOOK PLACE IN THE FOLLOWING WEEKS, THE PATIENT NEVER REACHED THE SAME DEGREE OF CONTROL ONE YEAR AFTER. 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
    252506 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention