BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 11236090 · Received January 27, 2021

    Report

    Report Number
    3006630150-2021-00164
    Event Type
    Injury
    Date Received
    January 27, 2021
    Date of Event
    January 9, 2021
    Report Date
    January 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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-2218-50, SERIAL: (B)(4), BATCH: 7072424/7072425.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. SYMPTOM OF DISCOMFORT AT THE POCKET SITE WAS NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL COMPONENTS WERE EXPLANTED AND DISCARDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136095 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 252149 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention