BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2803082 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09484
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND THE HIGHEST LEVEL ONLY GOES TO A 3 AND IT USED TO GO TO 10 OR 11. IT WAS ALSO REPORTED THAT IT SEEMS RANDOM WHEN SHE MOVED OR CHANGED POSITIONS SHE WOULD GET A SHARP SHOCK THAT WOULD GO DOWN ON HER HIP TO THE DEVICE. THE PATIENT AND MANUFACTURER REPRESENTATIVE THOUGHT THE WIRE WAS LOSS AND DID SOME TROUBLESHOOTING AT THE DOCTOR'S OFFICE FOR THE PAST FEW MONTHS. THE DOCTOR WAS ABLE TO CHECK IT A MONTH AND A HALF AGO VIA X-RAY AND DID NOT SEE ANY LOOSE WIRES. THE DOCTOR WANTED THE PATIENT TO CONTINUE TROUBLESHOOTING WITH THE REPRESENTATIVE, BUT THE PATIENT HAD NOT SEEN THE REPRESENTATIVE IN A WHILE. THE PATIENT HAD AN APPOINTMENT TODAY WITH THE DOCTOR. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEE AT THE DOCTOR'S OFFICE AND WAS DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1