BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10584306 · Received September 24, 2020

    Report

    Report Number
    3006630150-2020-04454
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    September 4, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(6), BATCH: 7070085.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE IPG SITE. THE PATIENT HAD AN ENCLAVES POCKET THAT TENDER TO TOUCHED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS GIVEN ANTIBIOTICS. THE EXPLANTED IPG WAS NOT RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENTS LEAD WAS ALSO EXPLANTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE IPG SITE. THE PATIENT HAD AN ENCLAVES POCKET THAT TENDER TO TOUCHED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS GIVEN ANTIBIOTICS. THE EXPLANTED IPG WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042891 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 363361 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention