BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4113599 · Received September 24, 2014

    Report

    Report Number
    9614453-2014-02067
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    November 5, 2013
    Report Date
    May 19, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 387745, LOT# B0398172K, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 747260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 387745, LOT# B0398172K, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A REPLACEMENT PROCEDURE THERE WAS EXTENSION EROSION WHICH RESULTED IN FRACTURE OF THE EXTENSION INSULATION. THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION AND EXPLANT OF THE EXTENSION. EVENT RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER (HCP) FOR A CLINICAL STUDY REPORTED VIA A MANUFACTURING REPRESENTATIVE THAT NEUROSTIMULATION NO LONGER HAD EFFECT. A SYSTEM CHECK WAS DONE AND IMPEDANCES WERE IN RANGE. THE EXTENSION WAS FRACTURED SO A REVISION WAS DONE. THE INS AND EXTENSION WERE EXPLANTED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT INTERVENTIONS INCLUDED EXPLANTING AND REPLACING THE DEVICE. THERE WAS AN EXTENSION FRACTURE. THE EXTENSION WAS EXPLANTED AND REPLACED. DIAGNOSTICS INCLUDED SURGICAL OBSERVATION. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS EXTENSION EROSION WHICH RESULTED IN A FRACTURE OF THE EXTENSION INSULATION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF EFFECT. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. SEVERAL HOURS AFTER THE PROCEDURE THE PATIENT NOTICED SHOCKING STIMULATION. THERE WAS A REPLACEMENT OF A NEW IMPLANTABLE NEUROSTIMULATOR (INS) AND THE PROBLEM WAS RESOLVED. THE PATIENT RECEIVED ADEQUATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596158 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R