BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3133816 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08236
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 10, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS DIFFICULTY CHARGING DUE TO THE LOCATION OF THE GENERATOR. RELOCATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLANNED FOR (B)(6) 2013. THE INS WILL BE RELOCATED FROM THE BACK TO THE ABDOMEN AREA. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013 WHERE IT WAS NOTED THAT THEY HAD EXCELLENT RESULTS CHARGING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND EXCELLENT STIMULATION FOLLOWING THE POCKET REVISION PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY CHARGING. THE MANUFACTURER REPRESENTATIVE PLANNED TO MEET THE PATIENT IN THE CLINIC TO EVALUATE CHARGING HISTORY. IT WAS LATER REPORTED THAT IMPEDANCES WERE WITHIN NORMAL LIMITS AND NO MALFUNCTIONS WERE SEEN. THERAPY WAS GOOD; HOWEVER IT WAS DIFFICULT FOR THE PATIENT TO CHARGE IN THE POSTERIOR POCKET. IT WAS REPORTED THAT THE PLAN WAS TO MOVE THE POCKET ANTERIOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A POCKET REVISION WAS PERFORMED THE DAY PRIOR TO THIS REPORTED. THE PATIENT WAS DOING WELL. IT WAS NOTED CHARGING WOULD BE EVALUATED AT FOLLOW UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN EXPLANT WAS PLANNED. IT WAS NOTED THAT THE REASON WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS PLANNED FOR AN EXPLANT ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECEIVING THERAPY. THE REPORTER NOTED THAT THEY WERE NOT TOLD OF ANY SYMPTOMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DECIDED TO NOT HAVE HIS SPINAL CORD STIMULATION (SCS) EXPLANTED AND WOULD CONTINUE TO USE IT FOR HIS PAIN MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235773 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 Required Intervention