BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 18256246 · Received December 4, 2023

    Report

    Report Number
    3006630150-2023-07508
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    March 7, 2022
    Report Date
    February 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    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 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7070331. BRAND NAME: LINEAR 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7070100. BRAND NAME: LINEAR 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 5167719. BRAND NAME: CLIK X. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. BATCH: 25076106. BRAND NAME: CLIK X. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. BATCH: 25076106.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). BRAND NAME: LINEAR 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). BRAND NAME: LINEAR 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: (B)(6). BRAND NAME: CLIK X. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. BATCH: 25076106. BRAND NAME: CLIK X. UPN: M365SC43180. MODEL: SC-4318. SERIAL: N/A. BATCH: 25076106. THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE LEADS SC-2352-70, SERIAL NUMBERS (B)(6), AND CLIK ANCHORS SC-4318 LOT NUMBERS 25076106 HAVE NOT BEEN RETURNED BY THE MEDICAL FACILITY. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE, IFU PRODUCT LABEL. ADDITIONALLY, SYSTEM FAILURE 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. 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. WEAKNESS, CLUMSINESS, NUMBNESS OR PAIN BELOW THE LEVEL OF IMPLANTATION MAY BE EXPERIENCED IN ADDITION TO PERSISTENT PAIN AT THE STIMULATOR OR LEAD SITE, ALL OF WHICH ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT IN THE LOWER BACK WHEN THE DEVICE WAS TURNED ON. IN ADDITION, THE PATIENT EXPERIENCED NUMBNESS AND TINGLING IN THE ARM AND HAD SINCE TURNED THE DEVICE OFF. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY, AND WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT IN THE LOWER BACK WHEN THE DEVICE WAS TURNED ON. IN ADDITION, THE PATIENT EXPERIENCED NUMBNESS AND TINGLING IN THE ARM AND HAS SINCE TURNED THE DEVICE OFF. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY, AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398793 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 369061 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H