BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 24658896 · Received March 22, 2026

    Report

    Report Number
    3006630150-2026-01698
    Event Type
    Injury
    Date Received
    March 22, 2026
    Date of Event
    August 6, 2025
    Report Date
    March 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729836544
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD D2B: PRO CODE (PRODUCT CODE) CORRECTION TO FIELD H11: ADDITIONAL MFR NARRATIVE ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2202-45 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7132880 MODEL/CATALOG DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 45CM UNIQUE IDENTIFIER (UDI) #(B)(4) MODEL NUMBER/CATALOG NUMBER: DB-3128-55B SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 5002335 MODEL/CATALOG DESCRIPTION: 55CM 2X8 LEAD EXTENSION KIT UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-4600-C SERIAL NUMBER: N/A BATCH/LOT NUMBER: 32211214 AND 33133767 AND 35357579 MODEL/CATALOG DESCRIPTION: SURETEK BURR HOLE COVER KIT UNIQUE IDENTIFIER (UDI) # (B)(4) AND(B)(4). AND (B)(4). WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE CAUSE OF THE PATIENT EXPERIENCING IMPAIRED HEALING AND UNDERGOING A PROCEDURE IN WHICH THE LEADS WERE EXPLANTED WAS CONFIRMED BASED ON RECORD REVIEW, THE DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE FACILITY. A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THE DEVICE INDICATED THAT IT WAS SUCCESSFULLY PROCESSED ACCORDING TO REQUIREMENTS. THE DEVICE HISTORY REVIEW, 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 DISCARDED BY THE FACILITY AND NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW WAS PERFORMED ON THE DEVICE'S INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE NOT RETURNED AS SUCH PHYSICAL ANALYSIS WAS NOT CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT, AND THE CONCLUSION IS KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2202-45 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7132880. MODEL/CATALOG DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 45CM UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-3128-55B SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5002335 MODEL/CATALOG DESCRIPTION: 55CM 2X8 LEAD EXTENSION KIT UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-4600-C SERIAL NUMBER: N/A BATCH/LOT NUMBER: 32211214 AND 33133767 AND 35357579 MODEL/CATALOG DESCRIPTION: SURETEK BURR HOLE COVER KIT UNIQUE IDENTIFIER (UDI) # (B)(4). INVESTIGATION SUMMARY: DEVICE HISTORY RECORD REVIEW: DEVICE TECHNICAL ANALYSIS: LABELING REVIEW: INVESTIGATION CONCLUSION:

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION AT THE LEAD SITE ON THE LEAD SITE ON THE HEAD OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM AND DISPLAYED SCABBING AND IMPAIRED HEALING. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE DEVICES WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION AT THE LEAD SITE ON THE LEAD SITE ON THE HEAD OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM AND DISPLAYED SCABBING AND IMPAIRED HEALING. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE DEVICES WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417429 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2201-45DC 7074829 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention