BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19342381 · Received May 17, 2024

    Report

    Report Number
    3006630150-2024-03195
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 26, 2024
    Report Date
    August 12, 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 COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5093567. BRAND NAME: INFINION CX. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 5141491.

    Additional Manufacturer Narrative · 0

    DEVICE TECHNICAL ANALYSIS: THE RETURNED IPG SC-1160, SN (B)(6) WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE RETURNED LEAD SC-2317-50, SN (B)(6) LEAD PASSED INSPECTION AND REVEALED NO ANOMALIES OTHER THAN A CLEAN CUT. THIS DAMAGE TO THE DEVICE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A DEVICE DEFICIENCY. THE RETURNED LEAD SC-2317-50, SN (B)(6) LEAD PASSED INSPECTION AND REVEALED NO ANOMALIES OTHER THAN A CLEAN CUT. THIS DAMAGE TO THE DEVICE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A DEVICE DEFICIENCY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF THERAPY FROM THEIR SPINAL CORD STIMULATION (SCS) SYSTEM. THE PHYSICIAN CITED LACK OF PATIENT COMPLIANCE AS THE REASONING. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF THERAPY FROM THEIR SPINAL CORD STIMULATION (SCS) SYSTEM. THE PHYSICIAN CITED LACK OF PATIENT COMPLIANCE AS THE REASONING. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904967 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 357034 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention