BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3449676 · Received November 5, 2013

    Report

    Report Number
    3004209178-2013-20200
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Report Date
    October 16, 2013
    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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377845, LOT# V016618, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 355029, LOT# N070926, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 377845, LOT# V007916, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THE PATIENT HAD PAIN GOING DOWN THEIR LEFT LEG, BUT THEY WERE FEELING STIMULATION IN THEIR RIGHT LEG AND LOWER BACK. IT WAS FURTHER NOTED THE PATIENT NOTICED THE CHANGE IN STIMULATION LOCATION ABOUT ONE YEAR AGO AROUND THE TIME THEY HAD FALLEN. THE REPORTER STATED THEY TRIPPED OVER A BEDRAIL IN HIS KITCHEN AFTER NOT TURNING THE LIGHT ON. THE REPORTER FURTHER STATED THEY HIT THEIR KNEE AND SHIN AND THEY CAUGHT THEMSELVES WITH THEIR HAND. IT WAS NOTED THE PATIENT HAD THEIR PROGRAMMING "TWEAKED" BY A MANUFACTURING REPRESENTATIVE ABOUT ONE YEAR AGO. IT WAS FURTHER NOTED THE MANUFACTURING REPRESENTATIVE WAS NOT ABLE TO CHANGE THE PATIENT'S STIMULATION TO THE CORRECT LOCATION. THE REPORTER STATED THEIR HEALTHCARE PROFESSIONAL (HCP) HAD NOT DONE DIAGNOSTIC TESTS WITH THEIR LEADS. IT WAS NOTED THE PATIENT WAS TRYING TO SET UP AN APPOINTMENT WITH THEIR HCP AND MANUFACTURING REPRESENTATIVE TO HAVE THEIR PROGRAMMING TWEAKED. IT WAS FURTHER NOTED THE PATIENT'S HCP TOLD THEM THEY MAY NEED A NEW LEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT NEEDED AN ADJUSTMENT BECAUSE STIMULATION WAS NOT COVERING THE RIGHT AREA. THE REPORTER STATED THAT STIMULATION COVERED THEIR LOWER BACK "S1 AND UP A LITTLE BIT," DOWN THEIR RIGHT LEG, AND THE FRONT OF THEIR THIGHS. IT WAS NOTED THE PATIENT WANTED TO COVER SCIATIC PAIN DOWN THEIR LEFT LEG. IT WAS FURTHER NOTED THE PATIENT FELL A COUPLE OF MONTHS AGO. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570372 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Male