BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 19889326 · Received August 1, 2024

    Report

    Report Number
    3006630150-2024-05041
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL:(B)(6), BATCH: 7070835/7071839.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD SPINAL CORD STIMULATION (SCS) REMOVED DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WILL NOT BE RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217532 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 370199

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention