BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2429036 · Received January 26, 2012

    Report

    Report Number
    3004209178-2012-00525
    Event Type
    Injury
    Date Received
    January 26, 2012
    Report Date
    January 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3998 LOT# V372028 IMPLANTED: (B)(6) 2011 EXPLANTED: NA, EXTENSION MODEL 3708260 SERIAL# (B)(4) IMPLANTED: (B)(6) 2011 EXPLANTED: NA, ACCESSORY MODEL 74001 LOT# N251450 IMPLANTED: (B)(6) 2011 EXPLANTED: NA, PROGRAMMER MODEL 37743 SERIAL# (B)(4), ACCESSORY MODEL 37752 SERIAL# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT DUE TO CONCERNS OF HER HAVING AN INFECTION, THOUGH THE PHYSICIAN DIDN'T SEEM TO BELIEVE THIS WAS RELATED TO THE DEVICE. IT WAS UNCLEAR WHICH PORTIONS OF THE SYSTEM WERE EXPLANTED. CULTURES SHOWED NO EVIDENCE OF INFECTION, AND IT WAS REPORTED THAT THE PATIENT WAS DOING BETTER AND WANTED TO KNOW WHEN SHE COULD BE RE-IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE MONTHS AGO, THE PATIENT WAS REPAIRING A TOILET WHEN SHE FELT THE IMPLANTABLE NEUROSTIMULATOR (INS) MOVE FROM HER RIGHT ABDOMEN TO UP UNDER HER RIBS. THE PATIENT HAD IMMEDIATE PAIN FOLLOWING THIS INCIDENT, WHICH EVENTUALLY DISSIPATED. ONE WEEK AGO, THE PATIENT EXPERIENCED A BURNING SENSATION IN THE POCKET AREA. IMPEDANCES WERE NORMAL, EXCEPT FOR ELECTRODE 3 WHICH WAS OVER 4,000 OHMS. THE PATIENT WAS PROGRAMMED TO 0+, 1-, 2+. THE PATIENT STATED THAT THE BURNING PERSISTED WITH STIMULATION TURNED OFF, HOWEVER, THE PATIENT WAS UNABLE TO TURN STIMULATION OFF FOR SIGNIFICANT PERIODS OF TIME AS THE REQUIRED THE THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention