BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 8571485 · Received May 1, 2019

    Report

    Report Number
    3006630150-2019-01984
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 1, 2019
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: PRODUCT FAMILY: DBS-LINEAR LEAD: UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5082417. PRODUCT FAMILY: DBS-LINEAR LEAD : UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5113686. PRODUCT FAMILY: DBS-LINEAR LEAD: UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5070044. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: (B)(4), MODEL: DB-4600C, BATCH: 23403354. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: (B)(4), MODEL: DB-4600C, BATCH: 23198103. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: (B)(4), MODEL: DB-4605C, BATCH: 23021393. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE BURR HOLE COVER REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE, THE BURR HOLE LOCKING FEATURE MAY HAVE FAILED AS PHYSICIAN FOUND THE LEAD HAD MIGRATED. THE PHYSICIAN REPLACED THE LEAD AND USED A NEW BURR HOLE COVER. LATER THAT SAME DAY, THE PHYSICIAN DISCOVERED BOTH LEADS HAD RETRACTED, SO PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE EXPLANTED. PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364597 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 23198103 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention