BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 24612477 · Received March 16, 2026

    Report

    Report Number
    3006630150-2026-01532
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 4, 2026
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729966340
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: (B)(6). CATALOG DESCRIPTION: ARGYLE LEAD 45CM STERILE KIT. UDI: (B)(4). PHYSICAL ANALYSIS COULD NOT BE COMPLETED IN OUR LABORATORY, AS THE DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED. A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THESE DEVICES INDICATED THAT THEY WERE SUCCESSFULLY PROCESSED ACCORDING TO REQUIREMENTS. THE DHR DID NOT IDENTIFY ANY MANUFACTURING PROCESS-RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING PRODUCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE DHR REVIEW ENSURES EACH DEVICE MEETS REQUIRED SPECIFICATIONS AND ASSOCIATED TESTING PRIOR TO RELEASE FOR DISTRIBUTION/SALE. A LABELLING REVIEW WAS PERFORMED BASED ON THE DFU AND IT DID NOT REVEAL ANY ANOMALIES AS IT STATES A LOSS OF ADEQUATE STIMULATION IS A KNOWN RISK WITH THE USE OF DEEP BRAIN STIMULATION (DBS). THE DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE HOSPITAL. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, A LABELING REVIEW WAS CONDUCTED. THIS REVIEW DETERMINED THE REPORTED EVENT OF A LOSS OF ADEQUATE STIMULATION IS A KNOWN RISK ASSOCIATED WITH THE USE OF DEEP BRAIN STIMULATION (DBS) AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5003863. CATALOG DESCRIPTION: ARGYLE LEAD 45CM STERILE KIT. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) LEADS WERE NOT PLACED OPTIMALLY WHEN INITIALLY IMPLANTED RESULTING IN NO BENEFIT FROM THE THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) LEADS WERE NOT PLACED OPTIMALLY WHEN INITIALLY IMPLANTED RESULTING IN NO BENEFIT FROM THE THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601528 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2203-45 5002393 08714729966340

    Patients

    Seq Age Sex Outcome Treatment
    1