BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    MDR report key: 24769514 · Received April 2, 2026

    Report

    Report Number
    3006630150-2026-02017
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729966395
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT AS THE PATIENT WAS NOT CERTAIN OF THE EXACT EVENT DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5002918, CATALOG DESCRIPTION: ARGYLE EXTENSION 55 CM STERILE KIT, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    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. THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. A LABELLING REVIEW WAS PERFORMED BASED ON DFU AND IT DID NOT REVEAL ANY ANOMALIES AS IT STATES: IMPLANTED DEVICE COMPONENTS (STIMULATOR, LEAD, OR LEAD EXTENSION) MAY MOVE FROM ORIGINAL LOCATION OR WEAR THROUGH THE SKIN, WHICH MAY LEAD TO THE NEED FOR ADDITIONAL SURGERY AND IS A KNOWN RISK WITH THE USE OF DEEP BRAIN STIMULATION (DBS). THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, A LABELING REVIEW WAS CONDUCTED. THIS REVIEW DETERMINED THAT THE REPORTED EVENT OF EROSION IS A KNOWN INHERENT RISK WITH THE USE OF DEEP BRAIN STIMULATION (DBS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE EXTENSION SITE WHERE IT CONNECTS TO THE LEAD, RESULTING IN EXPOSURE OF THE LEAD EXTENSION. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE EXTENSION SITE WHERE IT CONNECTS TO THE LEAD, RESULTING IN EXPOSURE OF THE LEAD EXTENSION. THE PATIENT SUBSEQUENTLY UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585044 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-3216-55 5002996 08714729966395

    Patients

    Seq Age Sex Outcome Treatment
    1