BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1872209 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07955
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IPG HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING IMPLANTATION, AFTER THE LEADS WERE PLACED INTO THE IPG AND THE IPG WAS PLACED IN THE POCKET, IMPEDANCE READINGS WERE CHECKED AND WERE NOTED TO BE "OUT OF TOLERANCE". IT WAS NOTED THAT THE IPG HAD NOT BEEN PLACED IN THE POCKET PRIOR TO THE LEADS BEING CONNECTED. THE IPG WAS REMOVED FROM THE POCKET AND IT WAS NOTICED THAT THERE WAS FLUID IN THE LEAD CONNECTION/HEADER BLOCK. THE PHYSICIAN NOTED THAT THE HEADER BLOCK OF THE IPG FELT "LOOSE". THE IPG WAS REMOVED AND REPLACED. IMPEDENCE CHECKS WERE PERFORMED ON THE NEW IPG AND THE READINGS WERE WITHIN TOLERANCE. IT WAS SUSPECTED THAT THERE WAS A PROBLEM WITH THE FIRST IPG THAT WAS PLACED. THE PT RECOVERED WITHOUT SEQUELA. NO FURTHER DETAILS OR PT SYMPTOMS WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR PROGRAMMER: MODEL 37743, LOT # NKE152892N| LEAD: MODEL 3778, LOT # V476241032| EXPLANTED:| LEAD: MODEL 3778, LOT# V476241033| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA144222N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: