BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4241649 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21257
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 20, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 3550-39, LOT# N200282, IMPLANTED: 2009-(B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 39565-30 LOT# SERIAL# N174213004 IMPLANTED: 2009-06-08 PRODUCT TYPE LEAD, PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY RECEIVED ASSISTANCE FROM THE MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COUPLE OF YEARS PRIOR TO THE REPORT THE PATIENT GOT KICKED IN THEIR STIMULATOR AND IT WAS KNOCKED LOOSE. THE PATIENT WENT TO THE ER AND HAD X-RAYS TAKEN AND THEY WERE TOLD THAT IT HAD TO BUILD SCAR TISSUE AROUND IT. THE PATIENT WAS ABLE TO MOVE THE STIMULATOR AROUND WITH THEIR FINGERS AND IT BRUISED BADLY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722293 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