BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3242513 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12147
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    February 28, 2013
    Report Date
    June 28, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 377860, LOT#: V014603, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 37742, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 377860, LOT# V016650, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS SUSPECTED OF OVER-DISCHARGE (OD). IT WAS STATED THAT THERE WAS TELEMETRY ISSUES. THE MANUFACTURER REPRESENTATIVE THOUGHT THAT THIS MIGHT HAVE BEEN THE PATIENT¿S THIRD OD. THE MANUFACTURER REPRESENTATIVE WAS TO DO A PHYSICIAN MODE RECHARGE (PMR) AND CLEAR THE POWER-ON-RESET (POR) AND DETERMINE IF IT WAS IN FACT THE THIRD OD. THE PATIENT REPORTEDLY HAD NOT USED THE INS IN 4 MONTHS. THE PATIENT CALLED THE MANUFACTURER REPRESENTATIVE 3 WEEKS AGO AND TODAY WAS THE FIRST AVAILABLE APPOINTMENT. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT¿ WHEN FOLLOW UP HAS BEEN REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT INDICATED THAT THE IMPLANT WAS ¿NOT WORKING PERIOD.¿ IT WAS NOTED THAT THE IMPLANT HADN¿T WORKED IN 6 MONTHS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS SUSPECTED TO BE THE THIRD OVERDISCHARGE (OD). THE CLINICIAN PROGRAMMER INDICATED IT WAS DISCHARGED. THE PATIENT WAS ABLE TO CHARGE NORMALLY WITH SEVEN BARS BUT HAD ALSO OBSERVED THE POR AND END OF SERVICE (EOS) MESSAGES ON THE RECHARGER WHEN THE RECHARGE SESSIONS WERE INITIATED. THE DEVICE WOULD BE CHARGED FURTHER AND CHECKED WITH THE CLINICIAN PROGRAMMER TO CONFIRM BATTERY STATUS AS THE PATIENT MAY HAVE BEEN AT EOS DUE TO "THIRD STRIKE." THE PATIENT"S LAST STIMULATION WAS ABOUT TWO MONTHS PRIOR TO REPORT. IT WAS FURTHER REPORTED THAT THERE WAS AN END OF LIFE (EOL) DISPLAYED. THE DEVICE HAD BEEN CHARGED FOR ANOTHER HALF-HOUR AND THE EOS WAS CONFIRMED ON THE CLINICIAN PROGRAMMER. THE HEALTHCARE PROFESSIONAL (HCP) WANTED TO REPLACE THE INS. ABOUT THREE DAYS LATER, IT WAS STATED THAT THE OD WAS CONFIRMED AND THE PATIENT HAD "SEVERAL" IN THE PAST. THE CAUSE OF THE OD WAS PATIENT COMPLIANCE. A PMR WAS PERFORMED BUT IT WAS NOT SUCCESSFUL. SYMPTOMS INCLUDED INCREASED PAIN. THE PATIENT WENT HOME AND ATTEMPTED TO REACH POR BUT THE BATTERY WAS NOT SALVAGEABLE. THE PATIENT WAS DOING "OKAY" AND WAS SCHEDULED FOR A REPLACEMENT NEXT MONTH BUT THE DATE WAS UNKNOWN AT THE TIME. A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343223 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 00051 YR Required Intervention