BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 11608967 · Received April 2, 2021

    Report

    Report Number
    3006630150-2021-01363
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LEAD EXTENSION, SERIAL NUMBER (B)(4) WAS ANALYZED AND X-RAY INSPECTION OF THE LEAD EXTENSION REVEALED CABLES # 7 AND 8 WERE FRACTURED AFTER THE WELD IN THE DISTAL CONNECTOR STACK. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD BODY AND CONNECTOR SECTION OF THE LEAD. BENDING THE DISTAL END COULD ALSO CAUSE CABLE FRACTURES IN THE CONNECTOR SECTION OF THE LEAD. THE BROKEN CABLES ARE STILL CONTAINED INSIDE THE CONNECTOR. THE RETURNED LEAD EXTENSION, SERIAL NUMBER (B)(4) WAS ANALYZED AND X-RAY INSPECTION OF THE LEAD EXTENSION REVEALED CABLES # 1, 2, 7 AND 8 WERE FRACTURED AFTER THE WELD IN THE DISTAL CONNECTOR STACK. THIS TYPE OF DAMAGE TYPICALLY OCCURS WHEN EXCESSIVE TENSILE FORCE IS EXERTED ONTO THE LEAD BODY AND CONNECTOR SECTION OF THE LEAD. BENDING THE DISTAL END COULD ALSO CAUSE CABLE FRACTURES IN THE CONNECTOR SECTION OF THE LEAD. THE BROKEN CABLES ARE STILL CONTAINED INSIDE THE CONNECTOR. THE COMPLAINT OF HIGH IMPEDANCES WAS CONFIRMED THROUGH PRODUCT ANALYSIS. THE PROBABLE CAUSE HAS BEEN TRACED TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 , MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7070943.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ASSESSED THAT THERE WERE HIGH IMPEDANCES ON MULTIPLE CONTACTS. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE PHYSICIAN FIRST CHECKED THE CONNECTIONS IN THE POCKET AT THE IPG, AND IMPEDANCE ISSUES DID NOT RESOLVE. THEN THE PHYSICIAN TESTED THE IMPLANTED LEADS WITH THE OR TEST CABLE AND THERE WAS NO ISSUES AS THE LEAD IMPEDANCES WERE IN RANGE. THEN THE PHYSICIAN TESTED THE EXTENSION CONNECTED TO THE LEAD WITH THE OPERATING ROOM TEST CABLE AND HE SAW THE HIGH IMPEDANCES, AND THEREFORE HE THEN DECIDED TO REPLACE BOTH EXTENSIONS AND ALL HIGH IMPEDANCES WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ASSESSED THAT THERE WERE HIGH IMPEDANCES ON MULTIPLE CONTACTS. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE PHYSICIAN FIRST CHECKED THE CONNECTIONS IN THE POCKET AT THE IPG, AND IMPEDANCE ISSUES DID NOT RESOLVE. THEN THE PHYSICIAN TESTED THE IMPLANTED LEADS WITH THE OR TEST CABLE AND THERE WAS NO ISSUES AS THE LEAD IMPEDANCES WERE IN RANGE. THEN THE PHYSICIAN TESTED THE EXTENSION CONNECTED TO THE LEAD WITH THE OR TEST CABLE AND HE SAW THE HIGH IMPEDANCES, AND THEREFORE HE THEN DECIDED TO REPLACE BOTH EXTENSIONS AND ALL HIGH IMPEDANCES WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507979 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7070866 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention