BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 10131506 · Received June 8, 2020

    Report

    Report Number
    3006630150-2020-02380
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    February 11, 2020
    Report Date
    August 5, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729760542
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-3138-25 (SN: (B)(6)) THE RETURNED LEAD EXTENSION WAS ANALYZED AND INDICATED THE COMPLAINT OF THE IMPEDANCE ANOMALIES WAS CONFIRMED. THE PROXIMAL END CONNECTOR WAS FRACTURED WHERE TWO CABLES WERE ELECTRICALLY OPEN. THE LEAD WAS MOST LIKELY EXPOSED TO EXCESSIVE MECHANICAL FORCE WHEN IT WAS INSERTED INTO THE IPG PORT RESULTING IN THE FRACTURED PROXIMAL ARRAY AND DAMAGED CABLES. SC-3138-25 SN: (B)(6). THE RETURNED LEAD EXTENSION WAS ANALYZED AND INDICATED THAT TWO CABLES WERE FRACTURED CLOSE TO THE PROXIMAL ARRAY. THE DEVICE FAILED THE IMPEDANCE MEASUREMENT TEST. SC-3138-25 SN: (B)(6). THE RETURNED LEAD EXTENSIONS WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD EXTENSIONS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS REPROGRAMMED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE HIGH IMPEDANCES WERE CLEARED. THE EXPLANTED DEVICES WILL BE RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: (B)(4), MODEL: SC-3138-25, SERIAL: (B)(4), BATCH: 1091426 / 1102581 / 1103419.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEAD EXTENSIONS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS REPROGRAMMED. TH PATIENT WAS DOING WELL POSTOPERATIVELY AND THE HIGH IMPEDANCES WERE CLEARED. THE EXPLANTED DEVICES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591146 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-25 7059434 08714729760542

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention