BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2971333 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02926
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 31, 2013
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS GOING IN FOR A REPLACEMENT THE TUESDAY FOLLOWING THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE BATTERY WAS REPLACED ON THE DAY OF REPORT. IT WAS REPORTED THE IMPEDANCES WERE ALL WITHIN NORMAL LIMITS AND THEY WERE ABLE TO GET ADEQUATE COVERAGE WITH STIMULATION IN POST OP BEFORE THE PATIENT LEFT THE HOSPITAL. IT WAS NOTED THE HOSPITAL RETAINED THE DEVICE AND THE PATIENT WAS GOING TO KEEP UP WITH RECHARGING ¿FROM THEN ON¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WARNING SCREEN ON BOTH PATIENT PROGRAMMER (PP) AND IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) WAS SEEN. LAST TIME THE PATIENT RECHARGED HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS ABOUT 2 WEEKS PRIOR TO THIS REPORT. THE LAST TIME SHE FELT THE STIMULATION WAS ONE DAY BEFORE. LAST NIGHT BEFORE SHE WENT TO BED IT STARTED TO HURT "IN HER HIP AND DOWN THE RIGHT LEG." IT WAS STATED THAT THIS WAS NERVE DAMAGE AND THESE PAINS WERE THE REASON FOR THE INS BEING IMPLANTED ORIGINALLY. THE PATIENT WAS GETTING A WARNING SCREEN TO CHARGE HER INSR. COUPLING AND/OR COMMUNICATION ISSUES WERE ALSO REPORTED. THE USE OF ANTENNA LOCATE (AL) FEATURE RESULTED IN A POWER ON RESET (POR) MESSAGE BEING DISPLAYED ON INSR WHICH THEN LEAD TO THE NORMAL RECHARGING SCREEN. ONE DAY LATER IT WAS STATED THAT THE PATIENT WAS NOT ABLE TO GET ANY BARS. THE PATIENT WAS CONFUSING COUPLING BARS WITH INS CHARGE LEVEL. A POR CONDITION WAS ALSO STATED. AFTER REVIEWING SOME BASIC FUNCTIONALITY OF THE PP, THE REPORTED ISSUE WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TEN DAYS LATER IT WAS REPORTED THE PATIENT HAD NOT HAD HER REPLACEMENT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76748 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 00067 YR Required Intervention