BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10067479 · Received May 18, 2020

    Report

    Report Number
    3006630150-2020-02104
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    April 27, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE 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: 7070501.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A HEMATOMA FORMING INFECTION ON THE TOP OF THE IPG AND THE IMPLANT WAS DRAINING. IT WAS NOTED THAT THE WOUND HAD OPENED AND THE PHYSICIAN CONFIRMED THAT IT WAS NOT DEVICE RELATED BUT RATHER PROCEDURE RELATED. THE PATIENT UNDERWENT A REVISION WHEREIN THE POCKET SITE WAS WASHED OUT, PLACED WITH ANTIBIOTICS AND SUTURED CLOSED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN ONGOING INFECTION. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A HEMATOMA FORMING INFECTION ON THE TOP OF THE IPG AND THE IMPLANT WAS DRAINING. IT WAS NOTED THAT THE WOUND HAD OPENED AND THE PHYSICIAN CONFIRMED THAT IT WAS NOT DEVICE RELATED BUT RATHER PROCEDURE RELATED. THE PATIENT UNDERWENT A REVISION WHEREIN THE POCKET SITE WAS WASHED OUT, PLACED WITH ANTIBIOTICS AND SUTURED CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531028 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 360781 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention