BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3231339 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11890
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 24, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD HIS IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED AND A LEAD CHANGED ON (B)(6) 2013. THE REPORTER STATED THAT THE INS AND LEAD ¿WENT DEAD.¿ IT WAS NOTED THAT THE PATIENT¿S STIMULATION MADE HIM THINK HE DIDN¿T HAVE STENOSIS ANYMORE ¿UNTIL IT BROKE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION. IT WAS NOTED THE PATIENT LAST FELT STIMULATION ON (B)(6) 2013 AND TURNED STIMULATION OFF. THE REPORTER STATED THERE WERE NO FALLS OR NO KNOWN ACCIDENTS OR INCIDENTS RELATED TO THIS EVENT. IT WAS NOTED THE PATIENT CHARGED THE INS OVER THE WEEKEND PRIOR TO THIS REPORT AND SAW THE IMPLANTABLE NEUROSTIMULATOR (INS) CHARGE COMPLETE ICON. IT WAS FURTHER NOTED THE PATIENT HAD ALL 8 COUPLING BOXES SHADED. THE REPORTER STATED ONCE THE INS WAS COMPLETELY CHARGED, THEY USED THE RECHARGER TO TURN THE INS ON AND SAW THE ON ICON, BUT DID NOT FEEL STIMULATION. IT WAS NOTED THE LAST TIME THE PATIENT RECHARGED WAS A MONTH PRIOR TO THIS REPORT. IT WAS NOTED THE PATIENT RECEIVED A REPOSITION ANTENNA MESSAGE WHEN TRYING TO START A NORMAL RECHARGE SESSION. IT WAS FURTHER NOTED THE PATIENT RECEIVED A POOR COMMUNICATION MESSAGE WITH AND WITHOUT THE ANTENNA ATTACHED WHEN USING THE PATIENT PROGRAMMER. THE REPORTER STATED THEY HAD A HARD TIME USING THE PATIENT PROGRAMMER SO THEY USED THE RECHARGER TO TURN THE INS ON AND OFF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT MANUFACTURING REPRESENTATIVE MEASURED IMPEDANCES OF >40,000 OHMS. IT WAS NOTED THE PATIENT HAD NO STIMULATION SENSATION IN THEIR RIGHT LEG AND THE RIGHT LEAD HAD IMPEDANCES >40,000 OHMS. IT WAS FURTHER NOTED THE LEFT LEAD WORKED FINE WITH IMPEDANCES BETWEEN 788-985 OHMS. THE REPORTER STATED IMPEDANCES WERE MEASURED TO BE >10,000 OHMS AND >40,000 OHMS WHEN THE VOLTAGE WAS INCREASED TO 3 VOLTS. IT WAS NOTED THE PROBLEM HAPPENED ¿ALL OF A SUDDEN¿ AND THE PATIENT WAS ¿NOT DOING ANYTHING.¿ IT WAS FURTHER NOTED THE PATIENT LOST THERAPY COVERAGE IN THEIR RIGHT LEG, LEAD 0-7. IT WAS NOTED THE PATIENT REQUESTED THE INS BE OFF INSTEAD OF PARTIAL COVERAGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES ON LEAD 0-7 WERE ALL OVER 10,000. IT WAS NOTED THE REVISION DATE WAS TO BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330775 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 00057 YR Required Intervention