BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 12848919 · Received November 19, 2021

    Report

    Report Number
    3006630150-2021-06593
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS: UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH/LOT: 7072570.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A WOUND CHECK AND NOTICE A REDNESS AT MIDLINE INCISION SITE. THE PATIENT PLACED ON ANTIBIOTICS AND SKIN CLEANING PROCESS. THE PHYSICIAN DID NOT BELIEVED THAT IT WAS DEVICE RELATED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743565 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 507849 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention