BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20330680 · Received September 30, 2024

    Report

    Report Number
    3006630150-2024-06506
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    July 24, 2018
    Report Date
    September 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS AFTER THE DEVICE WAS IMPLANTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 , MODEL: SC-2218-50 , SERIAL: (B)(6), BATCH: 7016579/5041960 . PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 , MODEL: SC-4318 , BATCH: 22062823.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND WAS EXPERIENCING SWELLING AND PAIN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE AND THE EXPLANTED DEVICE WAS NOT RETURNED. THE PATIENT WAS ADMINISTERED WITH INTRAVENOUS ANTIBIOTICS AND SPENT A WEEK IN THE HOSPITAL TO RECOVER. THE PATIENT WAS THEN SENT HOME WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603411 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 335670 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention