BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVEREDGE 32

    MDR report key: 9263181 · Received October 31, 2019

    Report

    Report Number
    3006630150-2019-06119
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    October 10, 2019
    Report Date
    April 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R UPN: M365SC11320 MODEL: SC-1132 SERIAL: (B)(6) BATCH: 202868

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: (B)(6) 2019. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PREVIOUS REPORT OF THE PATIENT UNDERGOING A SURGICAL REVISION PROCEDURE DUE TO A REPORTED LEAD MALFUNCTION INVOLVING FIXATE WAS CHANGED TO A REPORT OF THE PATIENT UNDERGOING A REVISION PROCEDURE DUE TO DISCOMFORT AT THE POCKET SITE. IT WAS REPORTED THAT THE EVENT IS RESOLVING. PHYSICIAN STATED THIS EVENT AS RELATED TO THE PROCEDURE AND THE DEVICE, BUT NOT RELATED TO STIMULATION.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A SURGICAL REVISION PROCEDURE DUE TO A REPORTED LEAD MALFUNCTION INVOLVING FIXATE. THE PHYSICIAN STATED THAT DEVICE DEFICIENCY DID NOT LEAD TO AN ADVERSE EVENT, OR TO A SERIOUS ADVERSE EVENT. NO FURTHER INFORMATION HAS BEEN REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PREVIOUS REPORT OF THE PATIENT UNDERGOING A SURGICAL REVISION PROCEDURE DUE TO A REPORTED LEAD MALFUNCTION INVOLVING FIXATE WAS CHANGED TO A REPORT OF THE PATIENT UNDERGOING A REVISION PROCEDURE DUE TO DISCOMFORT AT THE POCKET SITE. IT WAS REPORTED THAT THE EVENT IS RESOLVING. PHYSICIAN STATED THIS EVENT AS RELATED TO THE PROCEDURE AND THE DEVICE, BUT NOT RELATED TO STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED SPECIFYING THAT THE REPORTED DISCOMFORT AT THE IMPLANT SITE WAS SENSITIVITY AT THE THORACIC INCISION WITH PALPABLE LEAD WIRES.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A SURGICAL REVISION PROCEDURE DUE TO A REPORTED LEAD MALFUNCTION INVOLVING FIXATE. THE PHYSICIAN STATED THAT DEVICE DEFICIENCY DID NOT LEAD TO AN ADVERSE EVENT, OR TO A SERIOUS ADVERSE EVENT. NO FURTHER INFORMATION HAS BEEN REPORTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: UNKNOWN, SERIAL / LOT: UNKNOWN, DESCRIPTION: FIXATE SUTURING DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A SURGICAL REVISION PROCEDURE DUE TO A REPORTED LEAD MALFUNCTION INVOLVING FIXATE. THE PHYSICIAN STATED THAT DEVICE DEFICIENCY DID NOT LEAD TO AN ADVERSE EVENT, OR TO A SERIOUS ADVERSE EVENT. NO FURTHER INFORMATION HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053682 COVEREDGE 32 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8336-50 7032072

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention