BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20592509 · Received November 1, 2024

    Report

    Report Number
    3006630150-2024-07506
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    June 17, 2024
    Report Date
    February 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. 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 THE POSSIBLE RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION INCLUDE 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. LEAD MIGRATION, RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF. SYSTEM FAILURE, WHICH CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURES 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. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE NOT ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICE WAS 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 AND THE CONCLUSION IS NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STATED THE IMPLANTABLE PULSE GENERATOR (IPG) STIMULATION OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM TURNS OFF AND TURNS BACK ON WHEN THE REMOTE CONTROL IS BROUGHT CLOSER TO THE IPG, CAUSING INADEQUATE STIMULATION. REPROGRAMMING, RE-EDUCATION ON THE CHARGING TECHNIQUES, AND A NEW REMOTE CONTROL WERE PROVIDED BUT DID NOT RESOLVE THE ISSUE. DATABASE ANALYSIS WAS COMPLETED AND NO ANOMALIES WERE NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED AND IS DOING WELL POST OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STATED THE IMPLANTABLE PULSE GENERATOR (IPG) STIMULATION OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM TURNS OFF AND TURNS BACK ON WHEN THE REMOTE CONTROL IS BROUGHT CLOSER TO THE IPG, CAUSING INADEQUATE STIMULATION. REPROGRAMMING, RE-EDUCATION ON THE CHARGING TECHNIQUES, AND A NEW REMOTE CONTROL WERE PROVIDED BUT DID NOT RESOLVE THE ISSUE. DATABASE ANALYSIS WAS COMPLETED AND NO ANOMALIES WERE NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IPG WAS REPLACED AND IS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153463 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 18691970

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention