BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 11024164 · Received December 16, 2020

    Report

    Report Number
    3006630150-2020-06241
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    December 1, 2020
    Report Date
    January 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.BLOCK H6 PATIENT CODE: 3191: NO CODE AVAILABLE IS USED AS THERE IS NO CORRESPONDING FDA CODE FOR ADDITIONAL INTERVENTION OR SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPAIRED HEALING AT THE LEFT BURR HOLE INCISION SITE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PHYSICIAN IRRIGATED AND PERFORMED DEBRIDEMENT OF THE LEFT BURR HOLE COVER SITE AND THE LEFT LEAD AND LEAD EXTENSION CONNECTION SITE. THE PHYSICIAN INDICATED THAT THE PATIENT HAD A FACELIFT YEARS AGO WHICH DEVELOPED AN INFECTION IN THE SCALP WHICH REQUIRED TREATMENT. THERE WERE NO SIGNS OF INFECTION BUT THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WILL BE SEEING A PLASTIC SURGEON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT CONSULTED WITH THE PLASTIC SURGEON WHO CONFIRMED THAT THE REASON FOR THE IMPAIRED HEALING AND INFECTION WAS DUE TO PREVIOUS INFECTIONS DUE TO THE FACE LIFT PREVIOUSLY PERFORMED. THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM. THE DEVICES WERE DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: (B)(4), MODEL: DB-4600C, SERIAL: N/A, BATCH: 25625198. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7074854 AND 7076151. PRODUCT FAMILY: DBS-EXTENSION: UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7071078 AND 7079369.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPAIRED HEALING AT THE LEFT BURR HOLE INCISION SITE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PHYSICIAN IRRIGATED AND PERFORMED DEBRIDEMENT OF THE LEFT BURR HOLE COVER SITE AND THE LEFT LEAD AND LEAD EXTENSION CONNECTION SITE. THE PHYSICIAN INDICATED THAT THE PATIENT HAD A FACELIFT YEARS AGO WHICH DEVELOPED AN INFECTION IN THE SCALP WHICH REQUIRED TREATMENT. THERE WERE NO SIGNS OF INFECTION BUT THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WILL BE SEEING A PLASTIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486815 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 25109011 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention