BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6045478 · Received October 20, 2016

    Report

    Report Number
    3006630150-2016-03006
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    August 4, 2016
    Report Date
    August 4, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2218-50 SERIAL #: (B)(4) DESCRIPTION: LINEAR ST LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE BSN SALES REPRESENTATIVE CANNOT LOCATE THE LEAD AND BELIEVED THAT IT MAY HAVE BEEN ACCIDENTALLY WERE OFF. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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 Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN A LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN COVERAGE. DATABASE ANALYSIS RESULT SHOWED THAT THE IMPEDANCE MEASUREMENTS WERE OBSERVED AND CONFIRMED HIGH IMPEDANCES ON 6 CONTACTS IN PORT A AND 1 CONTACT IN PORT C. THE PROGRAM DETAILS REVEALED THAT THERE WERE ACTIVE CONTACTS WITH HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN A LEAD WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN COVERAGE. DATABASE ANALYSIS RESULT SHOWED THAT THE IMPEDANCE MEASUREMENTS WERE OBSERVED AND CONFIRMED HIGH IMPEDANCES ON 6 CONTACTS IN PORT A AND 1 CONTACT IN PORT C. THE PROGRAM DETAILS REVEALED THAT THERE WERE ACTIVE CONTACTS WITH HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN A LEAD WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN COVERAGE. DATABASE ANALYSIS RESULT SHOWED THAT THE IMPEDANCE MEASUREMENTS WERE OBSERVED AND CONFIRMED HIGH IMPEDANCES ON 6 CONTACTS IN PORT A AND 1 CONTACT IN PORT C. THE PROGRAM DETAILS REVEALED THAT THERE WERE ACTIVE CONTACTS WITH HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN A LEAD WILL BE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN COVERAGE. DATABASE ANALYSIS RESULT SHOWED THAT THE IMPEDANCE MEASUREMENTS WERE OBSERVED AND CONFIRMED HIGH IMPEDANCES ON 6 CONTACTS IN PORT A AND 1 CONTACT IN PORT C. THE PROGRAM DETAILS REVEALED THAT THERE WERE ACTIVE CONTACTS WITH HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN A LEAD WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694228 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR