BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 11871484 · Received May 24, 2021

    Report

    Report Number
    3006630150-2021-02346
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7073325.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LEAD REVISION PROCEDURE (MFR NUMBER 3006630150-2021-02332), THE PATIENT EXPERIENCED NUMBNESS AND DIFFICULTY MOVING THE LEFT LEG. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE RELATED, HOWEVER SUSPECTED THAT THE NEW LEADS WERE PUTTING TOO MUCH PRESSURE ON HER SPINAL CORD DUE TO SCAR TISSUE FROM THE PREVIOUS IMPLANT. THE PHYSICIAN ALSO SUSPECTED THAT THE SYMPTOMS COULD BE A SIDE EFFECT OF MEDICATION ADMINISTERED DURING THE PROCEDURE. AFTER SOME IMAGING AND OBSERVATION, THE PHYSICIAN OPTED TO TO EXPLANT THE LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766650 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 7073275 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention