BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10984564 · Received December 10, 2020

    Report

    Report Number
    3006630150-2020-06126
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    October 2, 2020
    Report Date
    December 10, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS , UPN: (B)(4), MODEL: SC-8336-70, SERIAL:(B)(4), BATCH: 7050282.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEVELOPED SEVERE SWELLING AROUND THE IPG AND LEAD SITES. IT WAS UNKNOWN IF THE SEVERE SWELLING WAS DEVICE OR PROCEDURE RELATED AS THE PHYSICIAN HAD NOT SEEN IT BEFORE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PRESCRIBED ANTIBIOTICS POST OPERATIVELY. THE EXPLANTED IPG AND PADDLE LEAD WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450662 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 360966 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention