BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3201056 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11168
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. THE BATTERY CAPACITY WAS REDUCED DUE TO OVERDISCHARGE. ANALYSIS OF THE LEAD FOUND NO SIGNIFICANT ANOMALY. THE OUTER INSULATION WAS MELTED. IT WAS SUSPECTED TO BE DUE TO CAUTERY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT ONE YEAR PRIOR TO THE REPORT THE PATIENT EXPERIENCED A FALL AND THE ¿STIMULATION NEVER FELT THE SAME.¿ IT WAS NOTED THE PATIENT DID NOT CONTACT THE MANUFACTURER FOR ASSISTANCE WITH TROUBLESHOOTING OR REPROGRAMMING AFTER THE FALL OCCURRED. IT WAS FURTHER NOTED THAT THE PATIENT STOPPED RECHARGING AND LET THE DEVICE GO INTO AN OVER DISCHARGE STATE. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE EXPLANTED. IT WAS NOTED THAT THE PATIENT WAS NOT INTERESTED IN REPROGRAMMING. IMPEDANCES WERE UNABLE TO BE CHECKED DUE TO THE OVER DISCHARGE STATE. THERE WERE NO PATIENT SYMPTOMS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303172 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