BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10548173 · Received September 17, 2020

    Report

    Report Number
    3006630150-2020-04281
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 12, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: (B)(4), MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7070743. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: (B)(4), MODEL: SC-4316, BATCH: 25184427.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO CHARGE THE IPG AS IT HAD FLIPPED AND WAS SCHEDULED FOR A POCKET REVISION. AT THE BEGINNING OF THE SURGERY, THE PHYSICIAN NOTICED THAT THE PATIENT HAD AN INFECTION. SYMPTOMS WERE REDNESS, SWELLING AND LEAKAGE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED AND BELIEVED THAT THE CAUSE WAS THE PATIENTS UNCONTROLLABLE DIABETES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015081 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365964 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention