BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 19635047 · Received June 28, 2024

    Report

    Report Number
    2124215-2024-39981
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 6, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    00191506023577
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-PC, UPN: M365DB14160, MODEL: DB-1416, SERIAL: (B)(6) , BATCH: 216012. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6) , BATCH: 7102949. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6) , BATCH: 7103000.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A RETURN OF THEIR PRE-IMPLANT TREMOR AS A RESULT OF INADEQUATE STIMULATION THERAPY. THE PHYSICIAN OBSERVED HIGH IMPEDANCE READINGS ON BOTH LEADS. THE PATIENT UNDERWENT AN EXPLORATORY PROCEDURE TO DETERMINE THE CAUSE OF THE HIGH IMPEDANCES, WHEREIN IT WAS DISCOVERED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD FLIPPED IN THE POCKET SEVERAL TIMES. THE PHYSICIAN ASSESSED THAT THE SUTURE LOOPS ON THE IPG LIKELY CAME UNDONE CAUSING THE IPG TO MOVE; AND AS A RESULT, THE TWISTING CAUSED DAMAGE TO THE LEAD EXTENSION RESULTING IN THE HIGH IMPEDANCE READINGS. THE LEADS REMAINED UNAFFECTED, AND THE LEAD EXTENSION WAS REPLACED. THE EXTENSION WAS RETAINED BY THE FACILITY AND NOT RETURNED FOR PHYSICAL ANALYSIS; THE LEADS AND IPG REMAIN IMPLANTED AND IN USE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215711 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-3128-55B 5000736 00191506023577

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention