BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8430551 · Received March 18, 2019

    Report

    Report Number
    3006630150-2019-01137
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    February 8, 2019
    Report Date
    October 21, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS COMPLETELY HEALED.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE LEAD SITE. IT WAS NOTED THAT FLUID FILLED THE POCKET LIKE THE SIZE OF A PEA AT THE LEAD SITE THAT WOULD FILL BACK UP AFTER A COUPLE OF DAYS. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED THE PATIENT WAS PRESCRIBED WITH ORAL ANTIBIOTICS AND VANCOMYCIN POWDER WAS ADMINISTERED. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5061588, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 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 INFECTION AT THE LEAD SITE. IT WAS NOTED THAT FLUID FILLED THE POCKET LIKE THE SIZE OF A PEA AT THE LEAD SITE THAT WOULD FILL BACK UP AFTER A COUPLE OF DAYS. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED THE PATIENT WAS PRESCRIBED WITH ORAL ANTIBIOTICS AND VANCOMYCIN POWDER WAS ADMINISTERED. THE PATIENT UNDERWENT AN INCISION AND DRAINAGE PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222704 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5061423 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention