BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19282324 · Received May 9, 2024

    Report

    Report Number
    3006630150-2024-03008
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    April 11, 2024
    Report Date
    August 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7093842/7094261/7099250.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7093842/7099250/7094261.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE AT THE IPG POCKET AND LEAD SITES. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE POCKET AND MIDLINE INCISIONS WERE WASHED OUT. THE INCISION SITES WERE LOOKING BETTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE AT THE IPG POCKET AND LEAD SITES. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE POCKET AND MIDLINE INCISIONS WERE WASHED OUT. THE INCISION SITES WERE LOOKING BETTER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DRAINAGE AT THE IPG POCKET AND LEAD SITES. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE POCKET AND MIDLINE INCISIONS WERE WASHED OUT. THE INCISION SITES WERE LOOKING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547746 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 594089 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention