BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 17170666 · Received June 21, 2023

    Report

    Report Number
    3006630150-2023-03566
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    January 1, 2019
    Report Date
    July 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY 2019. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5063096/5038641.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A IPG AND LEAD REVISION DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS COMPONENTS WERE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A IPG AND LEAD REVISION DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS COMPONENTS WERE DISCARDED. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD A SPINE FUSION BY ANOTHER SURGEON WHO DOES NOT DO SPINAL CORD STIMULATORS. THE PHYSICIAN SOMEHOW CAUGHT PART OF ONE OF THE LEADS WHILE DOING SURGERY AND THAT MANAGED TO PULL THE LEAD DOWN FROM WHERE IT HAD BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171994 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 343349 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention