BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15887779 · Received November 30, 2022

    Report

    Report Number
    3006630150-2022-06633
    Event Type
    Injury
    Date Received
    November 30, 2022
    Date of Event
    October 6, 2020
    Report Date
    November 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS PRIOR FROM THE DATE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500; MODEL: SC-8336-50; SERIAL: (B)(4); BATCH: 7031218.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG AND LEAD WERE EXPLANTED. NO FURTHER INFORMATION WAS OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761370 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 340478 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention