BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4047874 · Received August 29, 2014

    Report

    Report Number
    3004209178-2014-16125
    Event Type
    Injury
    Date Received
    August 29, 2014
    Report Date
    September 12, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (B)(4) FOUND THAT THE STIMULATION BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. IT WAS REPORTED THAT THE INS WAS RECEIVED WITH NO TELEMETRY AND NO OUTPUT. TELEMETRY WAS RESTORED AFTER ONE PHYSICIAN MODE RECHARGE (PMR). IT WAS STATED THAT THE INS PASSED FUNCTIONAL TESTING WHEN TELEMETRY WAS RESTORED. IT WAS DETERMINED THAT THE INS HAD EXPERIENCED TWO OVERDISCHARGES ACCORDING TO THE INS TRACE REPORT. IT WAS NOTED THAT THE FIRST OVERDISCHARGE WAS RECOVERED IN THE FIELD; HOWEVER, THE CLOCK WAS NOT RESET TO THE CURRENT TIME. DUE TO THIS FACT IT COULD NOT BE DETERMINED WHEN EITHER OF THE TWO OVERDISCHARGES OCCURRED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74002, LOT# N240233, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3998, LOT# LB2060, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-29, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4). 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

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR WAS GOING TO BE REPLACED FOR AN UNKNOWN REASON. COMPATIBILITY OF THE RECHARGING AND PROGRAMMING EQUIPMENT WITH A NEW STIMULATOR WAS REQUESTED. IT WAS NOTED THAT THE PATIENT¿S CURRENT EQUIPMENT WOULD NOT WORK WITH A 37714 OR 37712. IT WAS FURTHER REPORTED THAT THE BATTERY WAS BEING REPLACED DUE TO NORMAL DEPLETION, BUT THE STIMULATOR WAS ONLY 4 YEARS OLD. THE REPLACEMENT WAS SCHEDULED FOR THE FOLLOWING DAY (B)(6) 2014. IT WAS FURTHER REPORTED THAT THE PATIENT¿S DEVICE WAS IN A CONFIRMED OVERDISCHARGE (OD). IT WAS UNKNOWN IF A PHYSICIAN MODE RECHARGE (PMR) WAS DONE. THE PATIENT HAD TO CHARGE WEEKLY, WHICH HE NO LONGER WANTED TO DO, AND THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-RECHARGEABLE DEVICE. THE PATIENT¿S STATUS WAS ALIVE WITH NO INJURY. IT WAS FURTHER STATED ON (B)(6) 2014 THAT THE PATIENT WAS NON COMPLAINT WITH RECHARGING, WHICH LEAD TO THE OVERDISCHARGE. THE PATIENT HAS HAD NO COMPLAINTS ABOUT THE CURRENT/NEW STIMULATOR OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530631 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention