BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3910697 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-12472
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 10, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-39, EXPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3550-39, EXPLANTED: 2014 (B)(6); PRODUCT TYPE ACCESSORY (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PMR RECOVERY, THE TOTAL RECHARGE COUNT IS 97. THE LAST RECORDED RECHARGE SESSION PERFORMED WHILE THE DEVICE WAS IMPLANTED HAS THE DEFAULT DATE OF 03/01/2000. THE DEVICE WAS RECHARGED FOR 57 MINUTES AND THE BATTERY CHARGED FROM 2.245V TO 3.580V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS THE LAST PATIENT USAGE WAS ON (B)(6) 2013. THE BATTERY DISCHARGED TO THE LOCK MODE ON 6/24/2013. TESTING OF THE RECHARGE FUNCTION OF THIS INS FOUND IT TO BE FUNCTIONING NORMALLY. A NORMAL RECHARGE WAS STARTED MANUALLY AFTER TWO PHYSICIAN MODE RECHARGES. THE INS WAS PLACED IN A BODY TEMPERATURE OVEN WITH APPROXIMATELY 1CM OF SPACE BETWEEN THE INS AND THE CHARGER ANTENNA. THE RECHARGER HAD FULL COUPLING AND THE INS RECHARGED FOR 5 HOURS AND 27 MINUTES TO AN END VOLTAGE OF 4.000V. BATTERY DISCHARGES RAPIDLY.

    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 THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN OVERDISCHARGED AND WAS EXPLANTED ON 2014 (B)(6). IT WAS NOTED THAT THE LEAD WAS EXPLANTED AS WELL. IT WAS STATED THAT THE PATIENT HAD GOTTEN THE BATTERY TO START CHARGING, AND THEN IT ¿WENT DEAD AGAIN AND NEVER CAME BACK ON PRIOR TO EXPLANT.¿ IT WAS STATED THAT THE PATIENT HAD NO STIMULATION FROM THE RIGHT SIDE IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT MISSED THEIR APPOINTMENT. THE REPORTER STATED IT WAS UNKNOWN HOW THE PATIENT WAS DOING. THE REPORTER FURTHER STATED THAT THE PATIENT WAS FOLLOWED BY "PAIN MANAGEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386395 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention