BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15429781 · Received September 15, 2022

    Report

    Report Number
    3006630150-2022-04771
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    March 30, 2022
    Report Date
    October 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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)(4); BATCH: 7103399/7103172.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING SEVERE LOW BACK PAIN, SWELLING, EXTREME NAUSEA AND VOMITING. IT WAS SUSPECTED THAT THE PATIENT HAD BILATERAL LUMBAR PARASPINAL MUSCLE SPASM AND WAS GIVEN AN ANTISPASMODIC MEDICATION. THE PATIENT ALSO HAD EVIDENCE OF POSTOPERATIVE INFECTION. SYMPTOMS OF EXPRESSIBLE PURULENT FLUID AND ERYTHEMA AT BOTH IPG AND MIDLINE INCISION SITES, AS WELL AS SOME BLISTERING OF MIDLINE INCISION SITE. THE PHYSICIAN PRESCRIBED INTRAVENOUS (IV) ANTIBIOTICS AND THE PATIENT RECEIVED WOUND CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING SEVERE LOW BACK PAIN, SWELLING, EXTREME NAUSEA AND VOMITING. IT WAS SUSPECTED THAT THE PATIENT HAD BILATERAL LUMBAR PARASPINAL MUSCLE SPASM AND WAS GIVEN AN ANTISPASMODIC MEDICATION. THE PATIENT ALSO HAD EVIDENCE OF POSTOPERATIVE INFECTION. SYMPTOMS OF EXPRESSIBLE PURULENT FLUID AND ERYTHEMA AT BOTH IPG AND MIDLINE INCISION SITES, AS WELL AS SOME BLISTERING OF MIDLINE INCISION SITE. THE PHYSICIAN PRESCRIBED INTRAVENOUS (IV) ANTIBIOTICS AND THE PATIENT RECEIVED WOUND CARE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521478 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 531890 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention