BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4132696 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18087
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    May 27, 2010
    Report Date
    September 8, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 7752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) MOVES AROUND AND THEY HAVE HAD PAIN AT THE IMPLANT INCISION SITE SINCE THEY WERE IMPLANTED. THE IMPLANT SITE WAS NOT RED OR SWOLLEN AND THEY HAVE HAD NO FALLS OR TRAUMA. THE PATIENT HAS TRIED TURNING THE STIMULATION OFF HOWEVER WHETHER THE DEVICE IS ON OR OFF THEY STILL FEEL THE PAIN. AS A RESULT OF THE PAIN THE PATIENT HAD BEEN IN BED AND WSA UNABLE TO GET UP. THEY WERE IN BED SO LONG THEY ¿EVEN GOT BED SORES¿. THE PATIENT ALSO NOTED THEY HAD SCAR TISSUE. THEY WERE TAKING MEDICATION FOR THE PAIN BUT IT WAS NOT HELPING ANYMORE. INFORMATION REPORTED ON (B)(6) 2014 NOTED THE PATIENT IS NO LONGER WORKING WITH THEIR MANUFACTURER REPRESENTATIVE OR HEALTH CARE PROVIDER (HCP) TO RESOLVE THE ISSUES AND WANTS THE DEVICE REMOVED BECAUSE IT HAS STOPPED WORKING. INFORMATION OMITTED PERTAINING TO EVENTS 700274294 ¿ LACK OF EFFECT/PAIN, AN UNRELATED PUMP ISSUE WITH AN UNKNOWN PATIENT, AND FOR AN OVER-DISCHARGE EVENT. INFORMATION WAS ALSO ADMITTED PERTAINING TO THE PATIENT'S MEDICAL HISTORY AND RSD WHICH WAS PRESENT PRIOR TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610608 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 00048 YR