BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3926519 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12802
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 18, 2012
    Report Date
    June 18, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778, LOT# V673442010, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3778, LOT# V673442030, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37701, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888-33, LOT# V792971, SERIAL# IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 37743, SER AL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE PATIENT¿S STIMULATION SYSTEMS HAD TO BE REMOVED IN ORDER TO RECEIVE A PUMP AND THE OTHER SYSTEM MALFUNCTIONED. THE REPORTER STATED THEY THOUGHT THE WIRES WERE LOOSE AND NOT CONNECTED AT ALL SPOTS. THE REPORTER FURTHER STATED THEY THOUGH THIS HAD STARTED ABOUT TWO YEARS AGO. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT #3004209178-2014-12801.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THE DEVICE OR THERAPY, BUT THEY WERE WORKING WITH A PHYSICIAN OR MANUFACTURING REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING AN MRI OF THE NECK FOR SPINAL STENOSIS. THE TIMEFRAME WAS UNKNOWN. THE PATIENT¿S STIMULATOR HAD NOT BEEN WORKING FOR THE PAST 2 YEARS. THE PATIENT WAS ¿NEVER GIVEN A CONTROLLER WHEN THEY IMPLANTED THE DEVICE.¿ PATIENT OUTCOME AND INTERVENTION WERE NOT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403532 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR