BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALGOVITA SPINAL CORD STIMULATION

    MDR report key: 6139651 · Received December 1, 2016

    Report

    Report Number
    3010309840-2016-00010
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    July 13, 2016
    Report Date
    August 25, 2016
    Manufacturer
    NUVECTRA CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P130028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO LIMITED INFORMATION AND THE ABSENCE IF ANY UNIQUE IDENTIFIERS, NO INVESTIGATION CAN BE CONDUCTED. REGARDING THE STATEMENT ABOUT THE SOFTWARE/FIRMWARE ERROR, THERE HAVE BEEN 2 FIELD ACTIONS INITIATED, BOTH HAVE BEEN REPORTED TO THE FDA PER 21 CFR PART 806. REFERENCE FDA RECAL NUMBERS Z -1192-2016 THROUGH Z-1194-2016 AND Z -1600-2016. DUE TO ISSUES WITH THE PORTAL SET UP PROCESS, THIS MDR HAS NOT BEEN SUBMITTED. NUVECTRA IS ACTIVELY WORKING WITH THE ESG HELPDESK AT THE FDA (TICKET #S (B)(4)). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM (MW5064075). THE REPORT WAS FORWARDED TO NUVECTRA AND RECEIVED BY NUVECTRA ON (B)(6) 2016. THE REPORT STATES, "THE LEAD USED WITH ALGOVITA SCS DEVICE MADE BY NUVECTRA BROKE APART AND FRAGMENTS REMAIN IN THE PT'S BODY. HAPPENED TWICE ON 2 DIFFERENT LEADS. ALSO, THERE IS A SOFTWARE/FORMWARE ERROR IN ALGOVITA SCS THAT MAY RESULT IN CATASTROPHIC FAILURE OF IMPLANTED DEVICE KNOWN TO COMPANY BUT PERHAPS NOT REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788681 ALGOVITA SPINAL CORD STIMULATION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTABLE (PAIN RELIEF) LGW NUVECTRA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R