BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10782130 · Received November 3, 2020

    Report

    Report Number
    3006630150-2020-05334
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    April 20, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7070076/5170176/7056466/7070142.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG AND LEAD SITE. SYMPTOMS OF INFECTION WERE SWELLING, PAIN AND FEVER. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED HOWEVER, THE INFECTION HAD SPREAD FROM THE LAST REVISION PROCEDURE (MFR REPORT NUMBER 3006630150-2020-02028). THE PATIENT WAS PLACED ON ANTIBIOTICS. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242549 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 367315 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention