BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22612266 · Received July 25, 2025

    Report

    Report Number
    3006630150-2025-05878
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    May 20, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7081803. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7074711. UDI: (B)(4). DEVICE TECHNICAL ANALYSIS: X-RAY INSPECTION OF THE RETURNED IPG WAS PERFORMED AND REVEALED TWO FRACTURED FEEDTHRU FT WIRES, WHICH SERVE AS THE CASE GROUND. THESE FT WIRE FRACTURES LED TO HIGH OUT-OF-RANGE IMPEDANCE MEASUREMENTS AND INADEQUATE STIMULATION EXPERIENCED BY THE PATIENT. THE LEADS WERE NOT RETURNED AS THEY REMAIN IMPLANTED IN THE PATIENT AND CONTINUE TO DELIVER DBS THERAPY. DEVICE HISTORY RECORD REVIEW: 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. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED, INDICATING THAT DEVICE FAILURE OR MALFUNCTION, INCLUDING BUT NOT LIMITED TO BATTERY FAILURE, LEAD OR EXTENSION BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS MAY LEAD TO A LOSS OF ADEQUATE STIMULATION AND A WORSENING OF DISEASE SYMPTOMS AND ARE KNOWN RISKS ASSOCIATED WITH THE USE OF DBS THERAPY AS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, LABELING PROVIDES SPECIFIC GUIDANCE TO CREATE A POCKET FOR THE IPG UNDER THE SKIN IN A LOCATION THAT IS EITHER IN THE CHEST OR IN THE ABDOMEN ON THE SAME SIDE OF THE PATIENT AS THE DBS LEAD(S) AND LEAD EXTENSION(S). INVESTIGATION CONCLUSION: ANALYSIS OF THE IPG REVEALED THAT THE FT CASE WIRES HAD BEEN SUBJECTED TO REPEATED STRESSES, RESULTING IN FRACTURE. THE IFU SPECIFIES THE DEVICE SHOULD BE IMPLANTED UNDER THE SKIN (SUBCUTANEOUS): HOWEVER, THE PHYSICIAN IMPLANTED THE IPG UNDER THE PECTORAL MUSCLE. THIS PLACEMENT IMPARTED ADDITIONAL AND FREQUENT MUSCLE TENSION FORCES ONTO THE IPG, WHICH MAY NOT OTHERWISE BE EXPERIENCED IF THE IPG HAD BEEN IMPLANTED SUBCUTANEOUSLY. THEREFORE, ENGINEERS CONCLUDED THAT THE INADEQUATE STIMULATION AND HIGH IMPEDANCE READINGS WERE CAUSED BY FRACTURED FT CASE WIRES, RESULTING FROM SUB-MUSCULAR IMPLANTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A RETURN OF PARKINSONIAN SYMPTOMS OF TREMOR AND RIGIDITY DUE TO INADEQUATE STIMULATION. UPON TROUBLESHOOTING, THE MONOPOLAR IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS WERE OBSERVED TO BE HIGH OUT-OF-RANGE. AS A RESULT, THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED AND HIGH IMPEDANCES RESOLVED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE PHYSICIAN NOTED THAT THE LOCATION OF THE IPG IMPLANT WAS SUBMUSCULAR IN THE PECTORAL REGION. BOSTON SCIENTIFIC LATER RECEIVED CONFIRMATION OF THE EVENT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A RETURN OF PARKINSONIAN SYMPTOMS OF TREMOR AND RIGIDITY DUE TO INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE PHYSICIAN NOTED THAT THE LOCATION OF THE IPG IMPLANT WAS SUBMUSCULAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A RETURN OF PARKINSONIAN SYMPTOMS OF TREMOR AND RIGIDITY DUE TO INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE PHYSICIAN NOTED THAT THE LOCATION OF THE IPG IMPLANT WAS SUBMUSCULAR. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CORRECT EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845985 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 514277 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention