BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 21145080 · Received January 13, 2025

    Report

    Report Number
    3006630150-2024-09509
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 13, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY SCS-LINEAR LEADS, UPN M365SC2366500, MODEL SC-2366-50, SERIAL-LOT (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY SCS-LINEAR LEADS, UPN M365SC2366500, MODEL SC-2366-50, SERIAL-LOT (B)(6). BATCH 7083317, 7083329, 7082482, 7081977.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) SITE, AND THE PATIENT EXPERIENCED DIFFICULTY CHARGING. THE PHYSICIAN ASSESSED THE PATIENT HAD AN INFECTION AT THE IPG SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PHYSICIAN DOES NOT KNOW IF THE INFECTION IS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT NOTHING HAPPENED DURING THE RECENT IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) SITE, AND THE PATIENT EXPERIENCED DIFFICULTY CHARGING. THE PHYSICIAN ASSESSED THE PATIENT HAD AN INFECTION AT THE IPG SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. THE PHYSICIAN DOES NOT KNOW IF THE INFECTION IS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211854 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 770494 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention