BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2894691 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00086
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 11, 2012
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL # (B)(4)) FOUND THE BATTERY HAD REDUCED CAPACITY DUE TO OVER DISCH ARGE. THE INS WAS RECEIVED IN AN OVERDISCHARGED CONDITION. TELEMETRY WAS RESTORED AFTER ONE PHYSICIAN MODE RECHARGE WAS PERFORMED. AFTER TELEMETRY WAS RESTORED, THE INS FUNCTIONED PROPERLY. ACCORDING TO THE TRACE REPORT TAKEN FROM THE INS, THE LAST RECHARGE DONE WHILE THE INS WAS IMPLANTED WAS ON (B)(6) 2012 AND THE BATTERY WAS RECHARGED FROM THE LOCK MODE TO 3.760 VOLTS. THE BATTERY DEPLETED BACK TO THE LOCK MODE ON (B)(6) 2012 WHICH WAS ALSO THE LAST RECORDED PATIENT USAGE. THREE OF THE LAST FIVE RECHARGES DONE WHILE THE INS WAS IMPLANTED SHOWED 8 BARS OF COUPLING 5-7 MINUTES INTO THE RECHARGE SESSION. ONE OF THE LAST FIVE RECHARGES SESSIONS SHOWED 0 BARS OF COUPLING AND ONE RECHARGE SESSION SHOWED 2 BARS OF COUPLING 5-7 MINUTES INTO THE RECHARGE SESSION. IN THE ANALYSIS LAB THE INS RECHARGED PROPERLY WITH 8 BARS OF COUPLING AT 1 CM SPACING BETWEEN THE INS AND RECHARGE ANTENNA.

    Additional Manufacturer Narrative · 1

    (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A PROBLEM WITH COMMUNICATING WITH THE BATTERY. THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE BATTERY AND THEY COULD NOT RECHARGE AFTER THEY HAD LET THE BATTERY GO FLAT ON MORE THAN TWO OCCASIONS. IT WAS NOTED THE EVENT WAS NOT NORMAL BATTERY DEPLETION. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3742 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