BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6872990 · Received September 18, 2017

    Report

    Report Number
    3004209178-2017-19533
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    May 1, 2017
    Report Date
    October 5, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 THE PATIENT REGARDING THEIR STIMULATOR (INS) IMPLANTED FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE STIMULATION TURNED OFF ON ITS OWN A FEW MONTHS BACK. SO PATIENT TURNED IT BACK ON. IT TURNED OFF AGAIN ON THE NIGHT OF (B)(6) 2017 ON ITS OWN. PATIENT STATED THAT WHEN HE TURNED IT BACK ON, THE STIM WAS FURTHER DOWN HIS LEGS INSTEAD OF THE MIDDLE OF HIS BACK. NO FALLS OR ACCIDENTS WERE REPORTED. PATIENT WORKED INSIDE A PRISON AND WONDERED IF THE GATES OR WAND COULD HAVE CAUSED IT. PATIENT DENIED PHONE NUMBER. HE SAID HE WAS AT WORK AND THERE WERE SO MANY PHONE NUMBERS. PATIENT CALLED AGAIN AND HAD HIS PATIENT PROGRAMMER WITH HIM. IT WAS REPORTED THAT PATIENT STILL FELT THE STIM IN HIS LEGS IN ALL POSITIONS. PATIENT WAS ASKED TO SYNCHRONIZE. PATIENT'S STIM WAS ON, ON PROGRAM A AND SAID UPRIGHT, AS PATIENT WAS SITTING UPRIGHT. IT APPEARED THAT PATIENT DID NOT HAVE ABILITY TO CHANGE PROGRAMS, AND DID NOT WANT TO DISABLE OR CHANGE ADAPTIVE STIM SETTINGS. PATIENT WAS GOING TO FOLLOW UP WITH HCP. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAD MET WITH A MANUFACTURING REPRESENTATIVE (REP) FOR REPROGRAMMING. THE REP DECREASED THE PULSE WI DTH TO BETTER COVER LOW-BACK AND POSTERIOR LEGS TO FEET; THE PATIENT IS HAPPY WITH THE RESULTS OF REPROGRAMMING. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT . IT WAS REPORTED THAT THEY CONTACTED THEIR HCP BUT WERE TOLD TO CONTACT THE MANUFACTURER. THE CAUSE AND INTERVENTIONS STATED BY THE PATIENT WAS THAT STIM TURNED OFF ON ITS OWN IN COUPLE OF MONTHS 2 TIMES. THE DATES AND TIMES WERE UNKNOWN. BOTH ISSUES WERE RESOLVED, PATIENT HAD TO USE THEIR PROGRAMMER TO TURN STIMULATION BACK ON. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652878 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR