BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4200820 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20385
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# V002328, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 WEEKS PRIOR TO REPORT THE PATIENT MET WITH THE MANUFACTURING REPRESENTATIVE AND THE MANUFACTURING REPRESENTATIVE HAD A HARD TIME FIND HER IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD LOST 40 POUNDS SINCE 2010 AND HER INS MOVED. THE PATIENT HAD NOT NOTICED THAT THE INS MOVED UNTIL SHE MET WITH THE MANUFACTURING REPRESENTATIVE. THE MANUFACTURING REPRESENTATIVE HAD TO MOVE THINGS AROUND AND THE INS DROPPED. THE PATIENT HAD TO PUT ANTENNA OVER A DIFFERENT PART OF HER REAR END, BUT IT STILL WORKED. THE PATIENT DID NOT PLAN ON GETTING THE POCKET REVISED AS LONG AS IT STILL WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679743 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1