BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4707679 · Received April 20, 2015

    Report

    Report Number
    3004209178-2015-07538
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Report Date
    March 30, 2015
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-45, LOT# V007087, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3487A-45, LOT# V040894, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION FOR OVER 6 MONTHS. A COMMUNICATION PROBLEM WAS REPORTED. THE PATIENT PROGRAMMER (PP) AND RECHARGER HAD NOT COMMUNICATED WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) IN OVER 6 MONTHS. THE PATIENT HAD NOT USED THE STIMULATOR IN OVER 6 MONTHS AND SHE WAS NOT SURE IF THE INS WAS DEAD OR NOT AND WAS WONDERING IF SHE COULD MEET WITH A MANUFACTURING REPRESENTATIVE (REP) TO GET IT GOING AGAIN. A COUPLE YEARS AGO SHE WAS ABLE TO MEET WITH A REP AND HE WAS ABLE TO GET THE INS GOING AGAIN. 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
    260669 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