BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3830582 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09580
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 25, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3877-45, LOT# 0207263529, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3877-45, LOT# 0207101044, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT MORE PAIN BECAUSE OF THE INEFFICIENCY OF THE DEVICE DUE TO CONTACT PROBLEM BETWEEN THE LEAD AND THE DEVICE. THERE WERE IMPEDANCES GREATER THAN 10,000 OHMS. INTERVENTION WAS NOTED AS TWO EXTENSIONS BEING CONNECTED. THE EVENT WAS NOTED AS ONGOING AND RELATED TO DEVICE, THERAPY, AND IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD WAS CONNECTED DIRECTLY TO THE DEVICE WITHOUT USING AN EXTENSION. THE LEAD WAS SHORT AND THIS CREATED A TENSION BETWEEN THE LEAD AND THE DEVICE AND IT WAS RESOLVED BY ADDING AN EXTENSION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THERE WAS POOR COMMUNICATION BETWEEN THE LEAD AND THE IMPLANTABLE NEUROSTIMULATOR (INS). THE LEAD WAS CONNECTED DIRECTLY TO THE DEVICE WITHOUT USING AN EXTENSION. THE ETIOLOGY WAS NOTED AS RELATED TO THE DEVICE SPECIFICALLY THE LEADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT MORE PAIN BECAUSE OF THE INEFFICIENCY OF THE DEVICE DUE TO CONTACT PROBLEM BETWEEN THE LEAD AND THE DEVICE. THERE WAS A POOR CONNECTION BETWEEN THE LEAD AND THE IMPLANTABLE NEUROSTIMULATOR (INS). THE LEAD WAS CONNECTED DIRECTLY TO THE DEVICE WITHOUT USING AN EXTENSION. INTERVENTIONS INCLUDED DEVICE SURGICAL REVISION. THE PATIENT EXPERIENCED A LOSS OF STIMULATION. THE ETIOLOGY WAS RELATED TO THE DEVICE OR THERAPY AND RELATED TO THE IMPLANT. THE EVENT WAS RELATED TO THE LEAD AND INS. ACTIONS TAKEN AS A RESULT OF THE EVENT INCLUDED ADDING TWO EXTENSIONS. THE ETIOLOGY WAS DUE TO THE LEAD. THE OUTCOME WAS ONGOING WITH NO FURTHER ACTION NEEDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT DID NOT FEEL THE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308381 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention