BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4102746 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17397
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 26, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377775, LOT# N0033896, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377775, LOT# N0033896, PRODUCT TYPE: LEAD. (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

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR ((B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY WAS AT NORMAL END OF LIFE/ELECTIVE REPLACEMENT INDICATOR OR END OF SERVICE.

    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 PATIENT WAS RECHARGING TWO DAYS PRIOR TO THE REPORT AND SAW THE ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS FURTHER REPORTED THAT THE PATIENT¿S STIMULATION STOPPED OVER TWO MONTHS AGO PER THE PATIENT AND THE PATIENT CAME IN FOR A DEVICE REPLACEMENT. THE PATIENT STATED THAT PRIOR TO THE TWO MONTHS, HER DEVICE WAS WORKING PERFECTLY. AT THE REPLACEMENT, THE HEALTH CARE PROFESSIONAL OPENED THE POCKET AND NOTICED SOME WHITE CLOUDY MATERIAL COMING OUT OF THE POCKET. THE HEALTH CARE PROFESSIONAL NOTICED THAT THE BATTERY HAD LEAKED IN THE PATIENT¿S POCKET. THE FASCIA AROUND THE AREA WAS EGGSHELL IN APPEARANCE. THERE WERE NO SIGNS OR SYMPTOMS OF INFECTION AND THERE WAS NO TENDERNESS, REDNESS, OR WARMTH. AT THAT TIME, A NEW BATTERY WAS HOOKED UP TO THE LEADS AFTER THEY WERE WIPED DOWN WITH GAUZE. THE PATIENT REPORTED ABSOLUTELY NO SYMPTOMS AND WAS FEELING WELL AFTER SURGERY. IT WAS FURTHER REPORTED THAT THE BATTERY HAD CORRODED AND THAT THE HEALTH CARE PROFESSIONAL SAW A MILKY SUBSTANCE COME OUT AFTER OPENING THE POCKET. THE REPORTER NOTED THAT THERE WAS A WHITE SUBSTANCE ON THE BATTERY, UP UNDERNEATH IT AND WHITE STUFF ALL IN THE IMPLANTABLE NEUROSTIMULATOR (INS). NEITHER THE MANUFACTURING REPRESENTATIVE NOR THE HEALTH CARE PROFESSIONAL THOUGHT IT WAS INFECTED. IT WAS NOTED THAT THE POCKET WAS LOOKING GOOD. IT WAS NOTED THAT THE LEADS LOOKED NORMAL. PRIOR TO THE REPLACEMENT, IMPEDANCES WERE LESS THAN 50 AND ONE OVER 10 ,000 AND THE REST WERE GOOD UP UNTIL END OF SERVICE (EOS) HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583880 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention