BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4781979 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-09383
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Report Date
    April 28, 2015
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2014 CRTS (B)(4) (CON): IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY PAIN RELIEF SINCE IT WAS IMPLANTED. THE CALLER STATED THAT THIS HAD BEEN SINCE THE TIME OF THE IMPLANT. THE CALLER WANTED TO SEE IF THE PATIENT COULD HAVE AN MRI. THE CALLER STATED THAT THE MRI WAS RELATED TO THE DEVICE OR THERAPY AND NOTED THAT ¿THE DEVICE WAS NOT WORKING FOR HIM.¿ THE CALLER NOTED THAT THEY WANTED TO DO THE MRI TO SEE IF THERE WAS ANOTHER PROBLEM GOING ON. THE CALLER STATED THAT THERE ¿MAY BE ANOTHER PROBLEM¿ AND ¿THEY DID NOT CATCH IT¿ AND SO THEY WERE DOING THE MRI. IT WAS NOTED THAT THE TRIAL WORKED BEAUTIFULLY BUT EVER SINCE THE PATIENT HAD THE PERMANENT ONE PUT IT THERE WAS ¿NO RELIEF NO CHANGE NO NOTHING.¿ THE CALLER STATED THE PATIENT WAS DOING ¿LAPS IN THE YARD, WALKING 300 FEET NO PROBLEM.¿ THE CALLER NOTED THAT THEY HAD TRIED REPROGRAMMING SEVEN OR EIGHT TIMES. THE CALLER WAS THE PATIENT¿S DAUGHTER. IT WAS LATER REPORTED THAT THE CALLER DID NOT KNOW IF THE MRI WAS RELATED TO THE DEVICE OR THERAPY BUT NOTED THE PATIENT STATED THE ¿IMPLANT WAS NOT WORKING.¿ THE CALLER WAS AN MRI TECHNICIAN. THE PATIENT WAS TO HAVE A LUMBAR SPINE MRI. ADDITIONAL INFORMATION RECEIVED REPORTED THAT MRI COMPATIBILITY GUIDELINES WERE REQUESTED. THE SCAN WOULD BE OVER THE IMPLANT. THE REASON FOR THE MRI WAS BECAUSE OF THE LOW BACK. THE PATIENT TOLD THE HEALTHCARE PROVIDER (HCP) THAT THE SPINAL CORD STIMULATOR (SCS) NEVER WORKED AND THEY WERE GOING TO BE SCANNING BECAUSE OF THE BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324869 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1