BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION MONTAGE

    MDR report key: 6017478 · Received October 11, 2016

    Report

    Report Number
    3006630150-2016-02801
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2408-56 SERIAL: (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT, 56 CM MODEL: SC-4319 LOT: 19027739 DESCRIPTION: CLIK X MRI ANCHOR MODEL: SC-3138-35 SERIAL: (B)(4) DESCRIPTION: SCS PHIII EXT 35CM MODEL: SC-4108 LOT: 19495775 DESCRIPTION: OR CABLE 2X8, 61CM AND EXTENSION SPECTRA LEAD SC-2408-56 S/N #(B)(4): THE COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED. THE LEAD PASSED ALL REQUIRED TESTS AND EXHIBITS NORMAL DEVICE CHARACTERISTICS. CLIK SC-4319 LOT #19027739: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE CLIK ANCHOR REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S TRIAL PROCEDURE WAS PROLONGED DUE TO HIGH IMPEDANCE READINGS ON THE LEAD AFTER THE ANCHOR WAS ATTACHED. THE PHYSICIAN CHOSE TO REPLACE THE LEAD, LEAD EXTENSION AND OR CABLE WHICH DELAYED THE PROCEDURE MORE THAN TWO HOURS. THE PATIENT EXPERIENCED PAIN DUE TO THE EXTENDED TIME IN THE SAME SURGICAL POSITION AND DIFFICULTY RISING THE FOLLOWING DAY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S TRIAL PROCEDURE WAS PROLONGED DUE TO HIGH IMPEDANCE READINGS ON THE LEAD AFTER THE ANCHOR WAS ATTACHED. THE PHYSICIAN CHOSE TO REPLACE THE LEAD AFTER TROUBLESHOOTING BY CHANGING CONNECTIONS WITH THE OR CABLE AND THE LEAD EXTENSION. THIS DELAYED THE PROCEDURE MORE THAN TWO HOURS. THE PATIENT EXPERIENCED PAIN DUE TO THE EXTENDED TIME IN THE SAME SURGICAL POSITION AND DIFFICULTY RISING THE FOLLOWING DAY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S TRIAL PROCEDURE WAS PROLONGED DUE TO HIGH IMPEDANCE READINGS ON THE LEAD AFTER THE ANCHOR WAS ATTACHED. THE PHYSICIAN CHOSE TO REPLACE THE LEAD AFTER TROUBLESHOOTING BY CHANGING CONNECTIONS WITH THE OR CABLE AND THE LEAD EXTENSION. THIS DELAYED THE PROCEDURE MORE THAN TWO HOURS. THE PATIENT EXPERIENCED PAIN DUE TO THE EXTENDED TIME IN THE SAME SURGICAL POSITION AND DIFFICULTY RISING THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669413 PRECISION MONTAGE SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other