BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 10027044 · Received May 5, 2020

    Report

    Report Number
    9614453-2020-01408
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    March 26, 2014
    Report Date
    May 5, 2020
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS ALREADY REPORTED IN MANUFACTURER¿S REPORT #3007566237-2020-00053; HOWEVER, SPECIFIC DEVICE INFORMATION WAS RECEIVED AFTER FOLLOWING UP WITH THE AUTHOR. ANY ADDITIONAL INFORMATION REGARDING THE EVENT WILL BE SUBMITTED AS A SUPPLEMENTAL SUBMISSION TO THIS REPORT. YEAR IS VALID, BUT EXACT DAY AND MONTH ARE NOT KNOWN. COUNTRY OF EVENT: FOREIGN REPORT SOURCE: (B)(6). OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389-40, SERIAL/LOT #: (B)(4), IMPLANTED: (B)(6) 2014, UDI#: (B)(4) ; PRODUCT ID: 7426, SERIAL/LOT #: (B)(4), UDI#: (B)(4) ; PRODUCT ID: 3389-40, SERIAL/LOT #: (B)(4), IMPLANTED: (B)(6) 2014, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 SUMMARY: 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. REPORTED EVENT: A (B)(6) YEAR OLD FEMALE PATIENT EXPERIENCED IDIOPATHIC EDEMA ALONG THE LEAD TRACK. THIS WAS LATER SUCCESSFULLY TREATED WITH CORTICOSTEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487732 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC EUROPE SARL 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention