BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 17618840 · Received August 24, 2023

    Report

    Report Number
    3006630150-2023-05044
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    January 28, 2023
    Report Date
    October 13, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY DBS-LEAD FIXATION. UPN M365DB4600C0. MODEL DB-4600C. LOT 25184441. BATCH 25184441. PRODUCT FAMILY DBS-LINEAR LEADS. UPN M365DB2202450. MODEL DB 2202-45. SERIAL (B)(6). BATCH 7072765 AND 7072915. PRODUCT FAMILY: DBS-EXTENSION UPN M365NM3138550 MODEL DB-3138-55 SERIAL (B)(6). BATCH 7076194 AND 7076295. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN M365DB1200S0. MODEL DB-1200S. SERIAL (B)(6). BATCH 742309.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY DBS-LEAD FIXATION, UPN M365DB4600C0, MODEL DB-4600C, LOT 25184441, BATCH 25184441. PRODUCT FAMILY DBS-LINEAR LEADS, UPN M365DB2202450, MODEL DB 2202-45, (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WOUND ISSUE AT THE DEEP BRAIN STIMULATION (DBS) RIGHT BURR HOLE INCISION SITE. THE PATIENT NOTED A SCAB WHICH APPEARED APPROXIMATELY SIX MONTHS AGO. THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE. DURING THE PROCEDURE, WHEN PHYSICIAN SHAVED THE PATIENTS HEAD, THE DBS LEAD INSIDE THE SCAB WAS VISIBLE. NO DEVICES WERE EXPLANTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR SEVERAL WEEKS. CULTURES WERE TAKEN WHICH CONFIRMED RARE STAPHYLOCOCCUS LUGDUNENSIS. THE PATIENT HAS BIT MORE TREMOR BUT IS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS WOUND ON HIS HEAD DID NOT HEAL. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED POSTOPERATIVELY AND THERE WAS A SMALL BRAIN BLEED BY THE RIGHT LEAD AFTER IT WAS REMOVED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. ALL NEUROLOGICAL TESTING WAS NORMAL. THE PATIENT LATER UNDERWENT ANOTHER CT SCAN, WHICH CAME BACK NORMAL. THE PATIENT HAS BEEN DISCHARGED AND NO OTHER MEDICAL INTERVENTION WILL BE DONE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WOUND ISSUE AT THE DEEP BRAIN STIMULATION (DBS) RIGHT BURR HOLE INCISION SITE. THE PATIENT NOTED A SCAB WHICH APPEARED APPROXIMATELY SIX MONTHS AGO. THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE. DURING THE PROCEDURE, WHEN PHYSICIAN SHAVED THE PATIENTS HEAD, THE DBS LEAD INSIDE THE SCAB WAS VISIBLE. NO DEVICES WERE EXPLANTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR SEVERAL WEEKS. CULTURES WERE TAKEN WHICH CONFIRMED RARE STAPHYLOCOCCUS LUGDUNENSIS. THE PATIENT HAS BIT MORE TREMOR BUT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639067 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 24326150 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H