BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 9800933 · Received March 6, 2020

    Report

    Report Number
    3006630150-2020-01036
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    February 10, 2020
    Report Date
    March 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD IMPLANT SITE AT THE BASE OF THE NECK AND UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM. THE PATIENT WAS SCHEDULED TO UNDERGO A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION, WHICH WAS CONFIRMED WITH AN X-RAY. DURING THE PROCEDURE THE PHYSICIAN NOTED PUSS AT THE LEAD INCISION SITE, THE PHYSICIAN THEN OPTED TO EXPLANT ALL THE DEVICES. THE PATIENT INDICATED FEELING SORENESS AT THE LEAD INCISION SITE. IT IS UNCLEAR WHAT MAY HAVE CAUSED THE INFECTION. A CULTURE WAS TAKEN, BUT THE RESULTS ARE NOT AVAILABLE. THE PATIENT WAS PLACED ON ANTIBIOTICS AND IS DOING WELL POST-OPERATIVELY. THE DEVICES ARE IN ROUTE TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE RESULTS OF THE CULTURE WOULD NOT BE RELEASED BY THE FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR ST, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5130548. BRAND NAME: PRECISION SPECTRA, UPN: (B)(4), MODEL: SC-1132, SERIAL: (B)(4), BATCH: 21467436.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD IMPLANT SITE AT THE BASE OF THE NECK AND UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM. THE PATIENT WAS SCHEDULED TO UNDERGO A LEAD REVISION PROCEDURE DUE TO LEAD MIGRATION, WHICH WAS CONFIRMED WITH AN X-RAY. DURING THE PROCEDURE THE PHYSICIAN NOTED PUSS AT THE LEAD INCISION SITE, THE PHYSICIAN THEN OPTED TO EXPLANT ALL THE DEVICES. THE PATIENT INDICATED FEELING SORENESS AT THE LEAD INCISION SITE. IT IS UNCLEAR WHAT MAY HAVE CAUSED THE INFECTION. A CULTURE WAS TAKEN, BUT THE RESULTS ARE NOT AVAILABLE. THE PATIENT WAS PLACED ON ANTIBIOTICS AND IS DOING WELL POST-OPERATIVELY. THE DEVICES ARE IN ROUTE TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265372 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5130544 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention