BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3832872 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09621
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 7, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE HAD IMPEDANCES OF GREATER THAN 10 ,000 OHMS ON ELECTRODES ZERO THROUGH SEVEN. IT WAS NOTED THE PATIENT ONLY USED STIMULATION AT 1.7 V SO IMPEDANCE TESTING WAS NOT PERFORMED HIGHER THAN 0.7 V. IT WAS REPORTED THE LEADS AND EXTENSIONS WERE PLANNED FOR REPLACEMENT WITH SURESCAN LEADS. IT WAS NOTED THE PATIENT HAD POSITIONAL CHANGES WITH STIMULATION AND WANTED TO REPLACE THE STIMULATOR WITH A SENSOR STIMULATOR. IT WAS REPORTED THE PATIENT WAS REPROGRAMMED USING ELECTRODES EIGHT THROUGH FIFTEEN. IT WAS NOTED THE PATIENT WAS NOT GETTING THE COVERAGE THEY HAD. IT WAS REPORTED THE PATIENT HAD LESS THAN FIFTY PERCENT THERAPY RELIEF IN THEIR LOW BACK AND BILATERAL LOWER EXTREMITIES. IT WAS NOTED THE PATIENT EXPERIENCED AN IMMEDIATE LOSS OF STIMULATION WHILE CHIPPING ICE. IT WAS FURTHER NOTED THE PATIENT DID NOT SLIP OR FALL ON THE ICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A REVISION/REPLACEMENT OF THE LEADS AND IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED IN RECOVERY WITH GOOD COVERAGE OF PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG), BOTH LEADS, AND BOTH EXTENSIONS WERE EXPLANTED. IT WAS NOTED THAT AN IPG AND TWO LEADS WERE IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS ¿NOT YET SCHEDULED¿ FOR A REPLACEMENT SURGERY. IT WAS FURTHER REPORTED THAT THERE WAS A CASE DATE OF (B)(6) 2014 WITH THE HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311094 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 Required Intervention