BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 16642157 · Received March 30, 2023

    Report

    Report Number
    3006630150-2023-01657
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    February 10, 2022
    Report Date
    March 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729893271
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9208150, MODEL: SC-9208-15, SERIAL: (B)(4), BATCH: 7030915; PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14320, MODEL: SC-1432, SERIAL: (B)(4), BATCH: 203019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF COVERAGE DUE TO S8 ADAPTERS HAD HIGH IMPEDANCES. IT WAS ALSO MENTIONED THE IPG HADE REACH END OF BATTERY LIFE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE ADAPTERS WHERE EXPLANTED AND A NEW IPG WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442538 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-9208-15 7021530 08714729893271

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention