BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 17602694 · Received August 23, 2023

    Report

    Report Number
    3006630150-2023-04981
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 24, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7126514/7130665.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. SYMPTOMS OF FEVER, REDNESS, AND CHILLS WERE NOTED. THE PATIENT RECEIVED TWO MAGNETIC RESONANCE IMAGING (MRIS) AND BOTH SHOWED THE INFECTION AS BEING SUPERFICIAL. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND THE PHYSICIAN REMOVED TWO CUBIC CENTIMETERS OF INFECTION. THE PATIENT UNDERWENT IPG EXPLANT PROCEDURE AND THE PATIENT WAS REPORTEDLY DOING WELL. PATIENT RETURNED THE EXPLANTED DEVICE TO THE HOSPITAL BECAUSE REP WAS NOT PRESENT DURING PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. SYMPTOMS OF FEVER, REDNESS, AND CHILLS WERE NOTED. THE PATIENT RECEIVED TWO MAGNETIC RESONANCE IMAGING (MRIS) AND BOTH SHOWED THE INFECTION AS BEING SUPERFICIAL. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND THE PHYSICIAN REMOVED TWO CUBIC CENTIMETERS OF INFECTION. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812628 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 573130 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention