BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 9010465 · Received September 12, 2019

    Report

    Report Number
    3006630150-2019-05009
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    August 14, 2019
    Report Date
    April 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL/LOT: (B)(6), BATCH: 5123080. UPDATE TO INITIAL MDR IN BOX E1 AND G1.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT APPROXIMATELY TWO MONTHS AFTER IMPLANTATION THE LEAD EXTENSION WAS EXPOSED OUTSIDE OF THE PATIENTS BODY. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN RE-IMPLANTED THE LEAD EXTENSION SUBCUTANEOUSLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT DEVICE: (B)(4), MODEL: NM-3138-55, 55 CM 8 CONTACT EXTENSION, SERIAL: (B)(4). IT IS INDICATED THAT THE LEAD EXTENSIONS WILL NOT BE RETURNED FOR EVALUATION THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT APPROXIMATELY TWO MONTHS AFTER IMPLANTATION THE LEAD EXTENSION WAS EXPOSED OUTSIDE OF THE PATIENTS BODY. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE PHYSICIAN RE-IMPLANTED THE LEAD EXTENSION SUBCUTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810904 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7040360 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention