BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2845004 · Received November 26, 2012

    Report

    Report Number
    3004209178-2012-10736
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    November 9, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_TLOCK_ANCHOR, PRODUCT TYPE ACCESSORY PRODUCT ID, NEU_TLOCK _ANCHOR, PRODUCT TYPE ACCESSORY PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (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.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE NEUROSTIMULATOR REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE BATTERY WAS OVER-DISCHARGED AND PERMANENTLY DAMAGED. FINAL DEVICE ANALYSIS OF THE LEAD #1 REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE BODY OF THE LEAD WAS SEGMENTED. FINAL DEVICE ANALYSIS OF THE LEAD #2 REVEALED THE FOLLOWING: THERE WERE NO SIGNIFICANT ANOMALIES FOUND. THE BODY OF THE LEAD WAS SEGMENTED. FINAL DEVICE ANALYSIS OF THE ANCHOR #1 REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND. FINAL DEVICE ANALYSIS OF THE ANCHOR #2 REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD ISSUES COMMUNICATING AND COUPLING WITH HER IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT STATED THAT SHE DID NOT NEED TO USE STIMULATION SO SHE HAD NOT CHARGED HER DEVICE FOR ABOUT EIGHT MONTHS. THE PATIENT WAS RECENTLY REAR ENDED IN A CAR ACCIDENT AND HER PAIN RETURNED SO SHE WANTED TO USE HER STIMULATION AGAIN. IT WAS REPORTED THAT THE INS WAS IN OVER DISCHARGE, AND THAT IT WAS THE PATIENT'S FIRST OVER DISCHARGE. TEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES BECAUSE OF THE CAR ACCIDENT, AND WAS GOING TO HAVE AN MRI ON HER HEAD REGION. IT WAS REPORTED THAT THE INS WAS SUCCESSFULLY PULLED OUT OF OVER DISCHARGE. IT WAS NOTED THAT THERE WAS NO PATIENT HOSPITALIZATION. THREE DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS FEELING PAIN AND A BURNING SENSATION AT THE INS LOCATION. IT WAS STATED THAT THE PREVIOUS FRIDAY, THE PATIENT HAD THE INS RECHARGED AND THE POWER-ON-RESET (POR) WAS CLEARED WITH THE CLINICIAN PROGRAMMER. AT THAT TIME, THE PATIENT HAD THERAPEUTIC STIMULATION. WHEN THE PAIN STARTED, THE PATIENT WAS INSTRUCTED TO TURN STIMULATION OFF, HOWEVER, THE SYMPTOMS PERSISTED. APPROXIMATELY ONE WEEK LATER, IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT AT THE INS SITE FROM CHARGING TWICE A DAY WHILE RETRAINING THE BATTERY TO HOLD A CHARGE. APPROXIMATELY 1.5 MONTHS LATER, IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED. IT WAS STATED THAT THE INS BECAME UNCOMFORTABLY HOT WHEN THE PATIENT WAS RECHARGING IT. THE PATIENT HAD TO CHARGE THE INS TWICE A DAY AFTER THE OVER-DISCHARGE. FURTHER INFORMATION WAS REQUESTED, BUT NONE WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT AS A RESULT OF THE DISCOMFORT THE PATIENT EXPERIENCED WHILE RECHARGING FOLLOWING THE OVERDISCHARGE, THE PATIENT AND THE HCP DECIDED IT WOULD BE BEST TO EXPLANT THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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