BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4258967 · Received November 18, 2014

    Report

    Report Number
    3004209178-2014-21783
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 26, 2014
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3587A25, LOT# N231018, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37712. SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR ((B)(4)) FOUND INSIGNIFICANT ANOMALIES AND WAS FUNCTIONALLY OKAY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS, THE TOTAL RECHARGE COUNT IS 152. THE LAST 5 RECORDED PATIENT RECHARGE SESSIONS OCCURRED BETWEEN (B)(6) 2014 AND (B)(6) 2014 WITH DURATION OF 9 SECONDS OR LESS. RECHARGE INFORMATION IN THE INITIAL REVIEW HAS TYPICAL COUPLING AT 50%. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2015; THE OVER DISCHARGE COUNT IS ZERO. TESTING OF THE RECHARGE FUNCTION OF THIS INS FOUND IT TO BE FUNCTIONING NORMALLY. A NORMAL CHARGE STARTED WITH THE INS AT BODY TEMPERATURE AND APPROXIMATELY 1CM OF SPACE BETWEEN THE INS AND CHARGER ANTENNA. THE CHARGE TIME WAS 3HOURS 35MINUTES AND THE INS CHARGED FROM 3.280V TO 3.925V WITH 100% COUPLING. CHARGING WAS INTERRUPTED TO OBTAIN THE IR AND TRACE REPORT. CHARGING RESUMED FOR 1 HOUR AND 32 MINUTES BRINGING THE BATTERY VOLTAGE TO 4.045V.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF ALL THREE OVERDISCHARGES WAS A "DEVICE MALFUNCTION." PATIENT SYMPTOMS ASSOCIATED WITH ALL THREE OVERDISCHARGES INCLUDED A LACK OF RELIEF AND NOT BEING ABLE TO ADJUST. THE DEVICE WAS RESTARTED/REBOOTED FOR THE FIRST AND SECOND OVERDISCHARGE. THE DEVICE WAS REPLACED AND THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A THIRD OVERDISCHARGE WAS CONFIRMED. IT WAS NOTED THAT A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED AND IT SUCCESSFULLY RESET THE DEVICE. IT WAS NOTED THAT IMPEDANCE TESTING WAS ALSO PERFORMED, AND NO IMPEDANCE ISSUES WERE PRESENT. PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED PAIN AND LESS THAN 50% THERAPY RELIEF AT THE LEFT SIDE IMPLANT. PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE ¿ NO INJURY.¿ THE PATIENT CONTINUED HAVING ISSUES WITH RECHARGING AND COUPLING AND BECAUSE OF THAT WAS NOT GETTING GOOD RELIEF. A COMPLETE DEVICE REPLACEMENT WAS REQUIRED ON (B)(6) 2014 AS A RESULT OF THE EVENT. IT WAS FURTHER NOTED THAT THE PATIENT WAS DOING MUCH BETTER WITH THE NEW IMPLANTABLE PULSE GENERATOR. THE REPORTER NOTED THAT IT WAS UNKNOWN WHEN THE PREVIOUS OVERDISCHARGE RESETS OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE DISPLAY WAS SHOWING ¿CALL YOUR DOCTOR¿ ICON. THE PATIENT REPORTED POWER ON RESET (POR) CONDITION. THE PATIENT SAW THE WARNING POR ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746672 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 00068 YR Required Intervention