BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALGOVITA SPINAL CORD STIMULATION SYSTEM

    MDR report key: 18047071 · Received October 31, 2023

    Report

    Report Number
    MW5147571
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Report Date
    October 30, 2023
    Manufacturer
    UNK
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/24/2023 FOR REPORT MW5147571 TO UPDATE THE MANUFACTURER. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    IT WAS REPORTED ON THE IMPLANT OF THE PREVIOUS INS, THE SURGEON USED A PREEXISTING INCOMPATIBLE LEAD, FROM NUVECTRA, AND THE PATIENT GOT GOOD COVERAGE. TODAY WE WERE GOING TO CHANGE THE BATTERY AND THE LEAD WAS DAMAGED PULLING IT OUT OF THE PREVIOUS INS. THE DR IS NOT A SURGEON AND COULD NOT REPLACE THE PADDLE LEAD. THE NEW INS WAS ALREADY OPENED TO GET THE WRENCH. DR IMPLANTED THE NEW INS WITH TWO PLUGS IN THE PORTS, SO WE CAN USE IT WHEN WE REPLACE THE LEAD WITH A SURGEON. FURTHERMORE IT WAS REPORTED THAT THE LEADS WERE FRACTURED, DAMAGED, OR BROKEN. THE NUVECTRA LEAD FRAYED WHEN IT WAS PULLED OUT OF THE PREVIOUS INS, AND REP STATES THEY WILL REPLACE THE NUVECTRA LEAD WITH A COMPATIBLE MANUFACTURER'S LEAD. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111864 ALGOVITA SPINAL CORD STIMULATION SYSTEM STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown