BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 8985886 · Received September 10, 2019

    Report

    Report Number
    3006630150-2019-04960
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 10, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729953432
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8336-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7010963, MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 70 CM. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN AUTOIMMUNE DISORDER FROM THE PAST. IT WAS ALSO REPORTED THAT FOLLOWING POST PLACEMENT OF SCS THE PATIENT WAS EXPERIENCING SERIOUS DRAINAGE AND WAS TREATED BY INFECTIOUS DISEASE PHYSICIAN. THE PHYSICIAN STATED THAT PATIENT HAD GROWN A NON-STAPHYLOCOCCAL ORGANISM. THE PATIENT WILL UNDERGO EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776672 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1060B 301378 08714729953432

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention