BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 19696898 · Received July 8, 2024

    Report

    Report Number
    3006630150-2024-04390
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 4, 2024
    Report Date
    September 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    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: BRAND NAME: LINEAR ST. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5072763. BRAND NAME: LINEAR ST. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5072760. SC-1132; (B)(6): THE IPG WAS RETURNED, ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2218-70; (B)(6): VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 24 CM FROM THE PROXIMAL END OF THE LEAD AND THE DISTAL PORTION OF THE LEAD WAS NOT RETURNED. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD ASIDE FROM THE CLEAN-CUT. SC-2218-70; (B)(6): VISUAL INSPECTION REVEALED THAT THE LEAD WAS CLEANLY CUT INTO TWO PIECES APPROXIMATELY 24 CM FROM THE PROXIMAL END OF THE LEAD AND THE DISTAL PORTION OF THE LEAD WAS NOT RETURNED. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. NO OTHER ANOMALIES WERE IDENTIFIED ON THE RETURNED PORTION OF THE LEAD ASIDE FROM THE CLEAN-CUT. A LABELING REVIEW WAS PERFORMED ON THE DEVICES INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. IT STATES SYSTEM FAILURE, WHICH CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURE(S) OF THE COMPONENTS OR THE BATTERY. THESE EVENTS, WHICH MAY INCLUDE DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS, AND LEAD INSULATION BREACHES, CAN RESULT IN INEFFECTIVE PAIN CONTROL. ALSO, UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE RETURNED AND ANALYZED, AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT IS KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR ST, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: (B)(6). BRAND NAME: LINEAR ST, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICES WERE DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICES WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167071 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 205153 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Required Intervention