BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 16702710 · Received April 7, 2023

    Report

    Report Number
    3006630150-2023-01875
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 7091926. PRODUCT FAMILY: DBS-IPG-R-MRI; UPN: M365DB12160; MODEL: DB-1216; SERIAL: (B)(6); BATCH: 522016. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; SERIAL: N/A; BATCH: 29238912. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 7090077. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7100198. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7100202.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: UNKNOWN, MODEL: UNKNOWN , SERIAL: UNKNOWN, BATCH: UNKNOWN; PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(4), BATCH: 522016.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM EXPLANTED DUE TO INFECTION AT THE LEFT CRANIAL BURR HOLE SITE. NO FURTHER INFORMATION COULD BE COLLECTED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM EXPLANTED DUE TO INFECTION AT THE LEFT CRANIAL BURR HOLE SITE. NO FURTHER INFORMATION COULD BE COLLECTED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414807 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 29280598 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention