BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20959209 · Received December 17, 2024

    Report

    Report Number
    3006630150-2024-08848
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 12, 2024
    Report Date
    April 14, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5071362. BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5023938. BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5071774. BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5017234. THE RETURNED IPG SC-1132, SN (B)(6) WAS ANALYZED AND THE EVENT OF DIFFICULTY CHARGING WAS CONFIRMED. THE IPG WAS UNABLE TO BE CHARGED, AND COMMUNICATION COULD NOT BE ESTABLISHED WITH EITHER A KNOWN WORKING REMOTE CONTROL (RC) OR CLINICIAN PROGRAMMER (CP). AS A RESULT, THE DATA LOGS COULD NOT BE RETRIEVED, AND NO FUNCTIONAL TESTING COULD BE CONDUCTED. UPON FURTHER INSPECTION, THE IPG WAS OPENED, AND INTERNAL ELECTRICAL MEASUREMENTS INDICATED EXCESSIVE SLEEP CURRENT AND LOW RESISTANCE AT A NODE WHERE HIGH RESISTANCE WAS EXPECTED. THIS FINDING CONFIRMS THAT THE APPLICATION-SPECIFIC INTEGRATED CIRCUIT (ASIC) CHIP WAS DAMAGED. SUCH DAMAGE IS TYPICALLY CAUSED BY THE IPGS EXPOSURE TO ELECTROCAUTERY WHICH IS LIKELY DUE TO AN UNINTENDED USER ERROR. THE PHYSICIANS IMPLANT MANUAL IDENTIFIES ELECTROCAUTERY AS A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL AND WARNS AGAINST THE USE OF ELECTROCAUTERY. ADDITIONALLY, THE LABELING REVIEW STATES THAT CERTAIN MEDICAL THERAPIES AND PROCEDURES MAY DEACTIVATE STIMULATION OR CAUSE PERMANENT DAMAGE TO THE STIMULATOR. PROCEDURES POSING SUCH RISKS INCLUDE LITHOTRIPSY, ELECTROCAUTERY, EXTERNAL DEFIBRILLATION, ULTRASONIC SCANNING, HIGH-OUTPUT ULTRASOUND, AND RADIATION THERAPY. NOTABLY, DAMAGE FROM RADIATION MAY NOT BE IMMEDIATELY DETECTABLE. FURTHERMORE, WHILE X-RAYS AND CT SCANS ARE UNLIKELY TO HARM THE STIMULATOR IF STIMULATION IS TURNED OFF, THEY MAY CAUSE DAMAGE IF STIMULATION REMAINS ACTIVE. IN SOME CASES, IRREVERSIBLE DAMAGE MAY NECESSITATE DEVICE EXPLANTATION. RETURNED LEAD SC-2366-50, SN (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. RETURNED LEAD SC-2366-50, SN (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. RETURNED LEAD SC-2366-50, SN (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. RETURNED LEAD SC-2366-50, SN (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5071362. BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5023938. BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5071774. BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 5017234.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A NON-DEVICE-RELATED PROCEDURE, THE PATIENT'S SPINAL CORD STIMULATION DEVICE WAS UNABLE TO BE CHARGED. THE PHYSICIAN ASSESSED THAT ELECTROCAUTERY MAY HAVE BEEN USED DURING THAT PROCEDURE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE; THEREFORE, THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS STABLE POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A NON-DEVICE-RELATED PROCEDURE, THE PATIENTS SPINAL CORD STIMULATION DEVICE WAS UNABLE TO BE CHARGED. THE PHYSICIAN ASSESSED THAT ELECTROCAUTERY MAY HAVE BEEN USED DURING THAT PROCEDURE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE; THEREFORE, THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS STABLE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437591 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1132 21807965

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention