BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 19382777 · Received May 23, 2024

    Report

    Report Number
    3006630150-2024-03325
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    May 2, 2024
    Report Date
    October 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 2000007265. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(6) MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7092506 / 7097380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FRACTURED LEAD, WHICH WAS CONFIRMED VIA X-RAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FRACTURED LEAD, WHICH WAS CONFIRMED VIA X-RAY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS ALSO HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584381 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 2000007265 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| O