BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 9570149 · Received January 9, 2020

    Report

    Report Number
    3007566237-2020-00053
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 6, 2019
    Report Date
    May 5, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WITH DEVICE INFORMATION REGARDING THE EDEMA EVENT. THIS EVENT, AND THE NEW INFORMATION RECEIVED, WERE SUBMITTED UNDER A SEPARATE REPORT. PLEASE SEE MANUFACTURER'S REPORT #9614453-2020-01408. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. EVENT COUNTRY NOTED AS (B)(6), HOWEVER IT IS IMPOSSIBLE TO DETERMINE IN WHICH COUNTRY THE EVENT OCCURRED. THE FACILITIES LISTED IN THE ARTICLE ARE (B)(6). AGE. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. 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. DANIELSSON A, CARECCHIO M, CIF L, ET AL. PALLIDAL DEEP BRAIN STIMULATION IN DYT6 DYSTONIA: CLINICAL OUTCOME AND PREDICTIVE FACTORS FOR MOTOR IMPROVEMENT. J CLIN MED. 2019;8(12). 10.3390/JCM8122163. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    DANIELSSON A, CARECCHIO M, CIF L, ET AL. PALLIDAL DEEP BRAIN STIMULATION IN DYT6 DYSTONIA: CLINICAL OUTCOME AND PREDICTIVE FACTORS FOR MOTOR IMPROVEMENT. J CLIN MED. 2019;8(12). 10.3390/JCM8122163. PALLIDAL DEEP BRAIN STIMULATION IS AN ESTABLISHED TREATMENT IN DYSTONIA. AVAILABLE DATA ON THE EFFECT IN DYT-THAP1 DYSTONIA (ALSO KNOWN AS DYT6 DYSTONIA) ARE SCARCE AND LONG-TERM FOLLOW-UP STUDIES ARE LACKING. IN THIS RETROSPECTIVE, MULTICENTER FOLLOW-UP CASE SERIES OF MEDICAL RECORDS OF SUCH PATIENTS, THE CLINICAL OUTCOME OF PALLIDAL DEEP BRAIN STIMULATION IN DYT-THAP1 DYSTONIA, WAS EVALUATED. IT WAS DETERMINED IN ONE PATIENT THAT THE ELECTRODES AND BATTERY WERE DISRUPTED AND WHEN THIS WAS DISCOVERED AND CORRECTED AN ABDOMINAL WOUND INFECTION DEVELOPED WHICH REQUIRED PROLONGED ANTIBIOTIC TREATMENT. THE PATIENT SUBSEQUENTLY IMPROVED. 3 YEARS LATER THE PATIENT HAD A RAPID LOSS OF SPEECH AND DIFFICULTY SWALLOWING WHICH REQUIRED A LEAD REPLACEMENT. THE PATIENT'S SPEECH AND SWALLOWING RETURNED TO NORMAL, HOWEVER THE PATIENT FAILED TO ACHIEVE >25% REDUCTION IN BFM MOVEMENT SCORE. IN ONE PATIENT AN IDIOPATHIC EDEMA ALONG THE LEAD TRACK WAS DISCOVERED. THIS WAS LATER SUCCESSFULLY TREATED WITH CORTICOSTEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34517 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention