BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 15339475 · Received September 1, 2022

    Report

    Report Number
    3006630150-2022-04434
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    August 4, 2022
    Report Date
    December 11, 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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 24985328.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 24985328.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 24985328. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7072556. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7074083. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7073383. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7073368. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB1200S0. MODEL: DB-1200-S. SERIAL: (B)(6). BATCH: 743127.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND TENDERNESS ON THE SCALP. THE PHYSICIAN ASSESSED THAT THESE SYMPTOMS WERE DUE TO AN INFECTION. IT IS UNKNOWN IF INFECTION IS DEVICE-RELATED. A BIOPSY AND CULTURE WAS TAKEN BUT THE RESULTS ARE UNKNOWN AT THIS TIME. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND TENDERNESS ON THE SCALP. THE PHYSICIAN ASSESSED THAT THESE SYMPTOMS WERE DUE TO AN INFECTION. A BIOPSY AND CULTURE WAS TAKEN BUT THE RESULTS ARE UNKNOWN AT THIS TIME. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT EXPERIENCED INFECTION SYMPTOMS OF SWELLING AROUND THE DEEP BRAIN STIMULATION (DBS) BURRHOLE COVERS AND AT THE LEADS/LEAD EXTENSIONS CONNECTION SITE. THE PHYSICIAN DID NOT BELIEVE THE INFECTION WAS DEVICE RELATED AND SUSPECTED THE PATIENTS PERSONAL HYGIENE AS THE CAUSE. THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND TENDERNESS ON THE SCALP. THE PHYSICIAN ASSESSED THAT THESE SYMPTOMS WERE DUE TO AN INFECTION. A BIOPSY AND CULTURE WAS TAKEN BUT THE RESULTS ARE UNKNOWN AT THIS TIME. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT EXPERIENCED INFECTION SYMPTOMS OF SWELLING AROUND THE DEEP BRAIN STIMULATION (DBS) BURRHOLE COVERS AND AT THE LEADS/LEAD EXTENSIONS CONNECTION SITE. THE PHYSICIAN DID NOT BELIEVE THE INFECTION WAS DEVICE RELATED AND SUSPECTED THE PATIENTS PERSONAL HYGIENE AS THE CAUSE. THE PATIENT WAS PLACED ON ANTIBIOTICS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE DUE TO THE REPORTED INFECTION. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633957 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 25291066 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention