BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4180516 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19883
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 10, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(5) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULDN¿T CHARGE BECAUSE ¿NOTHING WAS WORKING.¿ THE PATIENT HAD BEEN HAVING AN ISSUE ¿TRYING TO FIND THE INS¿ 6-8 MONTHS AGO. THE PATIENT HAD MET WITH A MANUFACTURER REPRESENTATIVE ¿OVER AND OVER AGAIN¿ TO REPROGRAM THE INS BECAUSE THE PATIENT¿S STIMULATION WAS ¿BOTHERING THE PATIENT.¿ THE PATIENT¿S HEALTHCARE PROVIDER (HCP) HAD DECIDED TO MEDICATE THE PATIENT RATHER THAN DEAL WITH THE STIMULATION THERAPY. THE PATIENT WAS ¿DEPRESSED ABOUT IT¿ AND HAD FELT LIKE THE STIMULATION WAS SHOCKING, RATHER THAN HELPING. THE PATIENT HAD THEN DECIDED TO QUIT USING THE INS, BUT NEEDED IT AGAIN AT THE TIME OF THIS REPORT. THE PATIENT HAD LAST FELT STIMULATION APPROXIMATELY 5 MONTHS AGO. THE PATIENT HAD LAST CHARGED THE INS APPROXIMATELY 5 MONTHS AGO. AN OVERDISCHARGE WAS SUSPECTED. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THE HCP FOR THE (B)(6). 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
    663128 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 00033 YR