BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20849297 · Received December 4, 2024

    Report

    Report Number
    3006630150-2024-08374
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7070412. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43160. MODEL: SC-4316. BATCH: 25603884.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A FULL SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A FULL SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977727 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 373792 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention