BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20141070 · Received September 4, 2024

    Report

    Report Number
    3006630150-2024-05883
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION-MRI. UPN: M365SC43190. MODEL: SC-4319. SERIAL: N/A. BATCH: 28953033. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7081145.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PRESENTS FOR POSTOPERATIVE WOUND CHECK IN LIGHT OF RECENT DRAINAGE. PATIENT HAD WOUND WASHOUT AND IMPLANTABLE PULSE GENERATOR (IPG) SITE RE-SUTURED. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PRESENTS FOR POSTOPERATIVE WOUND CHECK IN LIGHT OF RECENT DRAINAGE. PATIENT HAD WOUND WASHOUT AND IMPLANTABLE PULSE GENERATOR (IPG) SITE RE-SUTURED. THE PATIENT WAS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386068 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 760144 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other| R