BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4167345 · Received October 13, 2014

    Report

    Report Number
    3004209178-2014-19568
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Report Date
    September 22, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# V042627, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT# V042627, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HEALTH RELATED QUESTION REGARDING THEIR STIMULATION THERAPY FOR CHRONIC PAIN. THE PATIENT EXPLAINED THE ¿ISSUES¿ THEY HAD WITH THEIR ¿STEM¿ TO THE DOCTOR AND THE DOCTOR SUGGESTED THAT THE PATIENT CONTACT THE LOCAL MANUFACTURER REPRESENTATIVE TO HAVE THE ¿STEM¿ CHECKED OUT TO ENSURE IT WAS WORKING PROPERLY. THE DOCTOR ALSO NOTED THAT NEW UPDATES HAD BEEN DEVELOPED THAT MAY APPLY TO THE PATIENT¿S CURRENT ¿STEM¿ THAT MAY HELP. THE PATIENT MENTIONED THIS WAS THEIR SECOND DEVICE. IT WAS LATER REPORTED THAT THE PATIENT¿S STIM WAS POSITIONAL AND CUT OUT WHEN THE PATIENT MOVED AND CHANGED POSITIONS. IT HAD BEEN CHECKED BEFORE BUT THERE WAS NOTHING THAT COULD BE DONE. THE PATIENT EXPLAINED THEIR BODY MADE EXCESSIVE SCAR TISSUE AND IT CAUSED THE LEAD TO ¿PULL AWAY FROM THE DERMA.¿ THERE WERE STILL CONCERNS REGARDING THE DEVICE OR THERAPY BUT THE PATIENT WAS WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT (B)(6) 2014. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647793 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1