BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 8935561 · Received August 27, 2019

    Report

    Report Number
    3006630150-2019-04580
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: PRODUCT FAMILY: DBS-LINEAR LEAD, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5126940. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4). BATCH: 5081279. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: (B)(4), MODEL: DB-4600C, SERIAL: N/A, BATCH: 23403350. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PHYSICIAN DISCOVERED PATIENTS SKIN ERODING AROUND THE CONNECTOR BLOCK JOINING THE LEADS AND EXTENSIONS. THE PHYSICIAN DECIDED TO PERFORM AN EXPLANT PROCEDURE TO REMOVE THE LEAD AND EXTENSIONS. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC REGIMENT AND WILL BE RE-EVALUATED IN 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729454 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 5080586 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention