BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12921899 · Received December 2, 2021

    Report

    Report Number
    3006630150-2021-06899
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEAD. UPN: M365SC8352500. MODEL: SC-8352-50. SERIAL: (B)(6). BATCH: 7022364.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING AN ABDOMINAL PAIN AFTER A PERMANENT IMPLANT SURGERY. THE PATIENT WENT IN THE HOSPITAL AND HAD A TUBE THAT IS GOING DOWN THE NOSE ALL THE WAY TO THE STOMACH PROVIDING SOME SUCTION AND WAS ON A COMPLETE BOWEL REST. THE STIMULATION WAS TURNED OFF. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVES THAT THE PADDLE LEAD MIGHT HAVE BEEN PUTTING PRESSURE ON THE SPINAL CORD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. ALL EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING AN ABDOMINAL PAIN AFTER A PERMANENT IMPLANT SURGERY. THE PATIENT WENT IN THE HOSPITAL AND HAD A TUBE THAT IS GOING DOWN THE NOSE ALL THE WAY TO THE STOMACH PROVIDING SOME SUCTION AND WAS ON A COMPLETE BOWEL REST. THE STIMULATION WAS TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817941 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 523286 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention