BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8579802 · Received May 3, 2019

    Report

    Report Number
    3006630150-2019-02044
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(4) BATCH/LOT NUMBER: 202949 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE OF THE COMPLAINT DEVICE 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 · 0

    A REPORT WAS RECEIVED THAT THE PHYSICIAN HAD DIFFICULTY INSERTING THE OLD WIRES INTO THE NEW BATTERY. IT WAS ALSO REPORTED THAT THEY WERE BENT AND WHEN THE PHYSICIAN TESTED IT HIGH IMPEDANCES WERE NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED AND WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE OF THE COMPLAINT DEVICE 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 PHYSICIAN HAD DIFFICULTY INSERTING THE OLD WIRES INTO THE NEW BATTERY. IT WAS ALSO REPORTED THAT THEY WERE BENT AND WHEN THE PHYSICIAN TESTED IT HIGH IMPEDANCES WERE NOTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372607 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 202475 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention