BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11021745 · Received December 16, 2020

    Report

    Report Number
    3006630150-2020-06230
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    October 12, 2020
    Report Date
    December 16, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED SIX WEEKS FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7071490 / 7071754.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS IPG WAS PROTRUDING AND WAS NOT IN THE SAME LOCATION. IT WAS ALSO REPORTED THAT THE PATIENTS IPG WAS UNABLE TO TAKE A CHARGE. IT WAS NOTED THAT THE SAID SYMPTOMS STARTED WHEN THE PATIENT HAD A FALL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488636 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 369345 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention