BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 13540098 · Received February 16, 2022

    Report

    Report Number
    3006630150-2022-00526
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    January 20, 2022
    Report Date
    March 24, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729832669
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7030150. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 5083896. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 5082069. PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138250, MODEL: SC-3138-25, SERIAL: (B)(6), BATCH: 7070769.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: UNK, UPN: UNK, MODEL: UNK, SERIAL: UNK, BATCH: UNK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE BEING DISCHARGED, FOLLOWING A SPINAL CORD STIMULATOR TRIAL PROCEDURE WHERE THE DISTAL END OF THE LEAD WAS PLACED AT THE SEVENTH THORACIC VERTEBRA, THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE AND WAS UNABLE TO MOVE HIS EXTREMITIES. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE PHYSICIAN ASSESSED THAT THE CAUSE OF THE SYMPTOMS WAS A SMALL HEMATOMA THAT WAS NOT RELATED TO THE DEVICE. THE PATIENTS FUNCTION RETURNED TO NORMAL AND HE WAS RELEASED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE BEING DISCHARGED, FOLLOWING A SPINAL CORD STIMULATOR TRIAL PROCEDURE WHERE THE DISTAL END OF THE LEAD WAS PLACED AT THE SEVENTH THORACIC VERTEBRA, THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE AND WAS UNABLE TO MOVE HIS EXTREMITIES. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE PHYSICIAN ASSESSED THAT THE CAUSE OF THE SYMPTOMS WAS A SMALL HEMATOMA THAT WAS NOT RELATED TO THE DEVICE. THE PATIENTS FUNCTION RETURNED TO NORMAL AND HE WAS RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536745 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-50 7075116 08714729832669

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R