BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 6201675 · Received December 22, 2016

    Report

    Report Number
    3006630150-2016-03816
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2218-70 SERIAL #:(B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM. MODEL#: SC-3138-25 SERIAL #: (B)(4), DESCRIPTION: SCS PHIII EXT 25CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN WAS NOT ABLE TO REMOVE THE MISSING CONTACTS FROM THE PATIENT¿S BODY. NO FURTHER COURSE OF ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2218-70 SERIAL #:(B)(4) DESCRIPTION: LINEAR ST LEAD, 70CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT THE PATIENT¿S LEAD WAS HAVING HIGH IMPEDANCES. IT WAS ALSO CONFIRMED THAT SOME OF THE PATIENT¿S CONTACTS WERE BROKEN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS NOTED THAT THE PATIENT¿S LEAD WAS HAVING HIGH IMPEDANCES. IT WAS ALSO CONFIRMED THAT SOME OF THE PATIENT¿S CONTACTS WERE BROKEN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848570 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention