BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19038179 · Received April 3, 2024

    Report

    Report Number
    3006630150-2024-02055
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    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: BRAND NAME: COVEREDGE. UPN: (B)(4). MODEL: SC-8452-50. SERIAL: (B)(6). BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    BLOCK D6B: IPG MODEL SC-1232 REMAINS IMPLANTED. LEAD MODEL SC-8452-50 WAS RETAINED UPDATE TO BLOCK B5 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: COVEREDGE UPN: M365SC8452500, MODEL: SC-8452-50, SERIAL: (B)(6), BATCH: 7070570.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING, AND EDEMA AROUND THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) SITE. A BLOOD TEST WAS PERFORMED WHICH REVEALED THAT HER WHITE CELL COUNT WAS HIGH. THERE WERE NO SIGNS OR SYMPTOMS OF INFECTION AT ANY OF THE IMPLANT INCISION SITES. THE PHYSICIAN ASSESSED THAT IT WAS POTENTIALLY RELATED TO A STAPHYLOCOCCUS INFECTION THAT THE PATIENT HAS IN HER UPPER ARM. THE PATIENT WAS ADMINISTERED AMOXICILLIN ANTIBIOTICS. UPON FOLLOW-UP THE PHYSICIAN DISCOVERED THAT THE PATIENT EXPERIENCED A HEMATOMA IN THE IPG POCKET SITE. THE PHYSICIAN ASSESSED THAT THE HEMATOMA COULD HAVE CONTRIBUTED TO SOME OF THE PAIN THE PATIENT WAS HAVING IN HER FLANK. THE HEMATOMA WAS EVACUATED AND THE AND COVEREDGE X PADDLE LEAD WAS REPLACED WITH A ARTISAN PADDLE LEAD. IT WAS NOTED THAT THE PADDLE LEAD WAS INTACT WITH NO FRAYING, ETC. TO EXPLAIN THE SYMPTOMS. THE PATIENT IS DOING FINE POSTOPERATIVELY WITH NO COMPLICATIONS. THE IPG REMAINS IMPLANTED. THE EXPLANTED PADDLE LEAD WILL NOT BE RETURNED AS IT WAS RETAINED BY THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING, AND EDEMA AROUND THE SPINAL CORD STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) SITE. A BLOOD TEST WAS PERFORMED WHICH REVEALED THAT HER WHITE CELL COUNT WAS HIGH. THERE WERE NO SIGNS OR SYMPTOMS OF INFECTION AT ANY OF THE IMPLANT INCISION SITES. THE PHYSICIAN ASSESSED THAT IT WAS POTENTIALLY RELATED TO A STAPHYLOCOCCUS INFECTION THAT THE PATIENT HAS IN HER UPPER ARM. THE PATIENT WAS ADMINISTERED AMOXICILLIN ANTIBIOTICS. UPON FOLLOW-UP THE PHYSICIAN DISCOVERED THAT THE PATIENT EXPERIENCED A HEMATOMA IN THE IPG POCKET SITE. THE PHYSICIAN ASSESSED THAT THE HEMATOMA COULD HAVE CONTRIBUTED TO SOME OF THE PAIN THE PATIENT WAS HAVING IN HER FLANK. THE HEMATOMA WAS EVACUATED AND THE AND COVEREDGE X PADDLE LEAD WAS REPLACED WITH A ARTISAN PADDLE LEAD. IT WAS NOTED THAT THE PADDLE LEAD WAS INTACT WITH NO FRAYING, ETC. TO EXPLAIN THE SYMPTOMS. THE PATIENT IS DOING FINE POSTOPERATIVELY WITH NO COMPLICATIONS. THE IPG REMAINS IMPLANTED. THE EXPLANTED PADDLE LEAD WILL NOT BE RETURNED AS IT WAS RETAINED BY THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED AND VERIFIED THAT THE PHYSICIAN REPLACED THE ORIGINAL LARGER PADDLE LEAD WITH A SMALLER PADDLE LEAD. THIS WAS TO REDUCE THE SPINAL NERVE IRRITATION THAT RESULTED IN FLANK PAIN AFTER THE ORIGINAL LEAD IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728696 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 577887 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention