BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2926500 · Received January 23, 2013

    Report

    Report Number
    3004209178-2013-00863
    Event Type
    Injury
    Date Received
    January 23, 2013
    Report Date
    January 3, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL# (B)(4)) REVEALED THE FOLLOWING: ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS, THE TOTAL RECHARGE COUNT IS 15. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS (B)(6) 2012. THE DEVICE WAS RECHARGED FOR 2 HOURS AND 23 MINUTES. THE BATTERY CHARGED FROM 3.860V TO 4.020V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS PATIENT USAGE AFTER THIS RECHARGE SESSION. REDUCED BATTERY CAPACITY DUE TO OVER DISCHARGE. OVER DISCHARGE COUNT = 1. TESTING OF THE RECHARGE FUNCTION OF THIS INS FOUND IT TO BE FUNCTIONING NORMALLY. THE INS WAS CHARGED WHEN RECEIVED AT ROOM TEMPERATURE FOR 7 HOURS AND 1 MINUTE. THE BATTERY CHARGED FROM 3.460V TO 4.055V. THE BATTERY WAS THEN DISCHARGED TO LOCK MODE AND RECHARGED AT BODY TEMPERATURE WITH APPROXIMATELY 1CM OF SPACE BETWEEN THE INS AND CHARGER ANTENNA. THE CHARGE TIME WAS 5 HOURS AND 14 MINUTES. THE INS CHARGED FROM 3.595 TO 4.055V WITH 100% COUPLING. FINAL DEVICE ANALYSIS OF ONE LEAD (LOT# V802444027) REVEALED THE FOLLOWING: SUTURES WERE TIED DIRECTLY TO THE LEAD. THE #0 CONDUCTOR WIRE WAS BROKEN UNDER THE SUTURES DUE TO OVERSTRESS OR DAMAGE. FINAL DEVICE ANALYSIS OF ONE LEAD (LOT# V619050) REVEALED THE FOLLOWING: SUTURES WERE TIED DIRECTLY TO THE LEAD. THE CONDUCTOR WIRE HAD A SHORT BETWEEN CIRCUITS 1 AND 3 UNDER THE SUTURES DUE TO OVERSTRESS OR DAMAGE. FINAL DEVICE ANALYSIS OF ONE LEAD (LOT# V882270) REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. SUTURES WERE TIED DIRECTLY TO THE LEAD. THE DISTAL END OF THE LEAD WAS STRETCHED. THE #1 WIRE WAS BROKEN INSIDE THE CONNECTOR SLEEVE. CONTINUITY WAS ACCEPTABLE FROM WIRE TO #1 ELECTRODE, BUT THERE WAS AN OPEN CIRCUIT FROM WIRE TO #1 CONNECTOR SLEEVE. FINAL DEVICE ANALYSIS OF THE EXTENSION (SERIAL# (B)(4)) REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3888-45 LOT# V619050, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-33 LOT# V882270, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    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 INITIALLY REPORTED THAT A PATIENT HAD EXPERIENCED COUPLING AND/OR COMMUNICATION ISSUES. NONE OF THE 8 COUPLING BARS COULD BE FILLED IN. AFTER USING ANTENNA LOCATE FEATURE, IT WAS POSSIBLE TO FIND A SPOT ON PATIENT'S SKIN WHERE HE WOULD GET ALL 8 COUPLING BARS, HOWEVER, A SLIGHTEST MOVEMENT WOULD LOSE COUPLING. IT WAS ALSO STATED THAT THE PATIENT STILL HAD CONCERNS WITH HIS DEVICE/THERAPY BUT WAS WORKING WITH HIS DOCTOR/MEDTRONIC REPRESENTATIVE. APPOINTMENT DATE WAS NOT MENTIONED. IT WAS REPORTED THAT THE ENTIRE SYSTEM HAD BEEN REMOVED AND NOT REPLACED. IT WAS STATED THAT THE STIMULATION DID NOT RELIEVE PAIN AND IT WAS VERY DIFFICULT TO RECHARGE THE DEVICE. EXPLANT WAS SCHEDULED SINCE THE PATIENT WAS HAVING BACK SURGERY AT THE SAME TIME. NO PATIENT DEATH OR INJURY WERE REPORTED AND THE PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32924 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