BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 15636273 · Received October 19, 2022

    Report

    Report Number
    3006630150-2022-05648
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    August 26, 2022
    Report Date
    October 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352500; MODEL: SC-2352-50; SERIAL: (B)(4); BATCH: 7075339. PRODUCT FAMILY: SCS-IPG-R-MRI; UPN: M365SC12320; MODEL: SC-1232; SERIAL: (B)(4); BATCH: 543681. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352700; MODEL: SC-2352-70; SERIAL: (B)(4); BATCH: 7071948. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352700; MODEL: SC-2352-70; SERIAL: (B)(4); BATCH: 7074397. PRODUCT FAMILY: SCS-LEAD FIXATION; UPN: M365SC43180; MODEL: SC-4318; SERIAL: N/A; BATCH: 29451582. PRODUCT FAMILY: SCS-LEAD FIXATION; UPN: M365SC43180; MODEL: SC-4318; SERIAL: N/A; BATCH: 29280663.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED PURULENT DRAINAGE AND SWELLING AT THE LEAD SITE ON THE SACRAL HIATUS APPROXIMATELY A WEEK AFTER BEING IMPLANTED WITH THE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A PROCEDURE WHERE THE LEAD SITE WAS WASHED OUT. CULTURES TAKEN TESTED POSITIVE FOR ESCHERICHIA COLI. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT ANOTHER PROCEDURE TO REMOVE THE LEADS. HOWEVER, WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WAS OPENED, PURULENT DRAINAGE WAS OBSERVED, AND IT WAS DECIDED AT THAT TIME TO REMOVE THE ENTIRE SCS SYSTEM. THE PATIENT DID WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2886673 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7073582 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H