BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 7078967 · Received December 4, 2017

    Report

    Report Number
    3004209178-2017-24767
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    January 1, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE NOTING THAT THE PATIENT WAS HAVING PROBLEMS WITH THEIR BACK. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THEY WERE GOING TO SEE THEIR HEALTHCARE PROVIDER ON THE DAY OF THE REPORT, BECAUSE THEY WERE HAVING PROBLEMS. THE PATIENT STATED THAT THEY NEED THEIR DEVICE TO BE BACK ON, AS THEY ARE HAVING BURNING IN THEIR FOOT. THEY ADDED THAT THEIR FOOT HAS BEEN SO BAD; ¿THE NERVES.¿ THE PATIENT STATED THAT WHEN THEY USE THEIR IMPLANTABLE NEUROSTIMULATOR (INS), IT RELAXES THEIR FOOT, BUT NOW THEY HAVE BEEN SLEEPING EVERY DAY WITH A FAN ON THEIR FOOT. THEY ADDED THAT THIS YEAR THEIR FOOT SEEMS TO BE GETTING WORSE; IT GETS SWOLLEN, AND THERE IS A BURNING IN THEIR BACK. THEY MENTIONED THAT THEY CALLED THEIR HEALTHCARE PROVIDER LAST MONTH BECAUSE THEY COULDN¿T MOVE; IT FELT LIKE SOMEONE WAS STABBING THEM IN THEIR BACK. THE PATIENT NOTED THAT IT GETS WORSE WHEN THEY SIT DOWN. THEY INDICATED THAT THEY ARE A WORKAHOLIC, AND THEY MOW THEIR LAWN AND DO ALL KINDS OF PROJECTS. NOW, THE PATIENT¿S LEGS ARE GIVING OUT. THE PATIENT REPORTED THEY ARE LOSING STRENGTH IN THEIR LEGS, WHICH IS WHY THEY ARE GOING TO SEE THEIR HEALTHCARE PROVIDER. THEY ADDED THAT IT FEELS LIKE THEY HAVE BEEN GOING A THOUSAND JUMPING JACKS, AND THEIR LEGS ARE ALL WOBBLY. THE PATIENT NOTED THAT THEY CAN¿T EVEN CLIMB UP A LADDER. THEY WERE TRYING TO CLIMB ON THE TRAIN AND ALMOST FELL OFF. THE PATIENT DID NOT THINK THIS WAS RELATED TO THEIR DEVICE. THEY ADDED THAT THEY USED THEIR DEVICE FOR A LONG TIME, AND HAS BEEN USING IT ON AND OFF. THE PATIENT STATED THAT THE THERAPY DOES WORK, BUT THEY DO NOT NEED IT EVERY DAY. THEY MENTIONED THAT THEY KNOW THEIR DEVICE IS ¿DYING OUT¿, BECAUSE THEIR CHARGE DEPLETES FAST. THEY STATED THAT THEY WILL CHARGE IT FOR 4 HOURS, THEN USE IT FOR 20 MINUTES ON THEIR BACK, AND IT WILL BE DEAD AGAIN. THE PATIENT SAID THEY PROBABLY AREN¿T DOING SOMETHING RIGHT, AND HAS PRETTY MUCH STOPPED USING THE DEVICE. THE PATIENT WAS TO FOLLOW-UP WITH THEIR HEALTHCARE PROVIDER. INDICATION FOR USE INCLUDES NON-MALIGNANT PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859340 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR