BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 18576911 · Received January 24, 2024

    Report

    Report Number
    3006630150-2024-00226
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    December 28, 2023
    Report Date
    April 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION. UPN:M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 32091536. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 586198. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7110442. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7110413. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7119569. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN:M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 31666139. VISUAL INSPECTION OF NM-3138-55, SERIAL NUMBERS (B)(6), REVEALED THAT THE LEAD EXTENSIONS WERE SEVERED, AND THE REMAINING PORTIONS WERE NOT RETURNED. THE DAMAGE TO THE LEAD EXTENSIONS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. NO ANOMALIES WERE OBSERVED ASIDE FROM THIS DAMAGE. AN EXTERNAL VISUAL INSPECTION OF THE OF DB-4600C ((B)(6)) DID NOT REVEAL ANY ANOMALIES. VISUAL INSPECTION OF LEAD DB-2202-45, SERIAL NUMBER 7110413, REVEALED THAT THE LEAD WAS SEVERED APPROXIMATELY 42.5 CM FROM THE DISTAL END. THE DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. NO ANOMALIES WERE OBSERVED ON THE LEAD ASIDE FROM THIS DAMAGE. VISUAL INSPECTION OF LEAD DB-2202-45, SERIAL NUMBER (B)(6), REVEALED THAT THE LEAD WAS SEVERED APPROXIMATELY 41.5 CM FROM THE DISTAL END. THE DAMAGE TO THE LEAD IS A RESULT OF A TYPICAL EXPLANT PROCEDURE. NO ANOMALIES WERE OBSERVED ON THE LEAD ASIDE FROM THIS DAMAGE. EXTERNAL VISUAL INSPECTION OF THE DB-1216, SERIAL (B)(6), REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION UPN:M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 32091536. PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 586198. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7110442. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL:(B)(6). BATCH: 7110413. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7119569. PRODUCT FAMILY: DBS-LEAD FIXATION UPN:M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 31666139.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION, UPN:M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 32091536. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(6), BATCH: 586198. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7110442. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7110413. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7119569. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN:M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 31666139.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED AN INFECTION, EROSION OF THE LEAD EXTENSION HEADER, AND SCABBING THAT WAS SLOW TO HEAL OVER THE LEFT BURR HOLE COVER (BHC). THE PHYSICIAN EXPLANTED THE DBS SYSTEM. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CULTURES REVEALED PROPIONIBACTERIUM ACNE AND A RARE STAPHYLOCOCCUS AUREUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED AN INFECTION, EROSION OF THE LEAD EXTENSION HEADER, AND SCABBING THAT WAS SLOW TO HEAL OVER THE LEFT BURR HOLE COVER (BHC). THE PHYSICIAN EXPLANTED THE DBS SYSTEM. THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED AN INFECTION, EROSION OF THE LEAD EXTENSION HEADER, AND SCABBING THAT WAS SLOW TO HEAL OVER THE LEFT BURR HOLE COVER (BHC). THE PHYSICIAN EXPLANTED THE DBS SYSTEM. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CULTURES REVEALED PROPIONIBACTERIUM ACNE AND A RARE STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478334 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7119105 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention