BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERCISE

    MDR report key: 11518685 · Received March 18, 2021

    Report

    Report Number
    3006630150-2021-01078
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 25, 2021
    Report Date
    May 28, 2021
    Manufacturer
    OSYPKA AG
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: THE RETURNED B26 ADAPTOR DB-9418-15 SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TEST PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE RETURNED B26 ADAPTOR DB-9418-15 SERIAL NUMBER (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. WITH ALL AVAILABLE INFORMATION BOSTON SCIENTIFIC CONCLUDES THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS NO PROBLEM HAS BEEN DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE TO ELECTIVELY REPLACE THE IPG AN ISSUE OCCURRED WHEN TRYING TO CONNECT THE B26 ADAPTERS WHEREIN THE PHYSICIAN SUSPECTED THE ADAPTERS TO BE DEFECTIVE AS THEY WOULD NOT ADVANCE FAR ENOUGH TO MAKE THE CONNECTION TO THE PREVIOUSLY IMPLANTED LEADS. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A REPLACEMENT ADAPTER. THE PATIENT WAS NOTED TO BE STABLE FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: (B)(4), MODEL: DB-9418-15, SERIAL: (B)(4), BATCH: P32557006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO ELECTIVELY REPLACE THE IPG AN ISSUE OCCURRED WHEN TRYING TO CONNECT THE B26 ADAPTERS WHEREIN THE PHYSICIAN SUSPECTED THE ADAPTERS TO BE DEFECTIVE AS THEY WOULD NOT ADVANCE FAR ENOUGH TO MAKE THE CONNECTION TO THE PREVIOUSLY IMPLANTED LEADS. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A REPLACEMENT ADAPTER. THE PATIENT WAS NOTED TO BE STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413140 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY OSYPKA AG DB-9418-15 P32557006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention