BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 5417908 · Received February 8, 2016

    Report

    Report Number
    3010309840-2016-00002
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 24, 2017
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FUTURE RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4). NOT EXPECTED TO BE RETURNED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME GXY CORRECTED TO LGW. IMPLANT DATE (B)(6) 2015 CORRECTED TO (B)(6) 2015. REPROCESSOR NAME AND ADDRESS "GM" CORRECTED TO LEAVING SECTION BLANKED. DATE RECEIVED BY MANUFACTURER 01/21/2016 CORRECTED TO 07/13/2016. (B)(4). THE 12 ELECTRODE PADDLE LEAD MODEL 3101-60 LOT NUMBER W3088964 WAS RETURNED TO NUVECTRA AND EVALUATED BY SUBJECT MATTER EXPERT (SME) WHICH DETERMINED THE LEAD WAS FULLY FUNCTIONAL. THE LEAD WAS FOUND AT INTAKE WITH NO FRACTURE PRESENT. EVALUATION INCLUDED VISUAL AND ELECTRICAL CHALLENGES. A DEVICE HISTORY REVIEW (DHR) WAS ALSO PERFORMED, WHICH DID NOT REVEAL ANY ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 MONTHS POST PERMANENT IMPLANT OF THE 2 X 6 PADDLE ELECTRODE CONFIGURATION, A REVISION PROCEDURE WAS REQUIRED DUE TO A LEAD FRACTURE. THE 2X6 PADDLE ELECTRODE WAS EXPLANTED AND A MODEL NUMBER 3000-60 SERIAL NUMBER (B)(4) LEAD CONFIGURATION WAS PLACED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 MONTHS POST PERMANENT IMPLANT OF THE 2X6 PADDLE ELECTRODE CONFIGURATION, A REVISION PROCEDURE WAS REQUIRED DUE TO A LEAD FRACTURE. THE 2X6 PADDLE ELECTRODE WAS EXPLANTED AND A MODEL NUMBER 3000-60 SERIAL NUMBER (B)(4) 3X4X3X2 LEAD CONFIGURATION WAS PLACED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75725 ALGOVITA SPINAL CORD STIMULATION LEAD, SPINAL-CORD, TOTALLY IMPLANTED LGW NUVECTRA CORPORATION 3101-60 W3088964

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention