BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3011097 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03918
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 16, 2017
    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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE WINTER MONTHS THE PATIENT HAD BEEN HAVING INCREASED STATIC ELECTRICITY. WHENEVER THE PATIENT TOUCHED THINGS SUCH AS THE GARAGE DOOR HE FELT A SHOCKING SENSATION. THE PATIENT JUST HAD HIS DEVICE TURNED OFF AND HE CONTINUED TO FEEL STATIC ELECTRICITY. THE REPORTER INDICATED THAT THE PATIENT'S DEVICE AUTOMATICALLY TURNED ITSELF ON WHEN THE PATIENT WAS NEAR ANY SENSING EQUIPMENT SUCH AS A FAUCET OR PAPER TOWEL THAT CONTAINED A SENSOR. IT WAS UNCLEAR IF THE PATIENT WAS NEAR THOSE DEVICES WHEN THAT HAPPENED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT WHEN THEY PATIENT GOT NEAR CERTAIN DEVICES, THE DEVICES SUCH AS TOWEL DISPENSERS AND AUTOMATIC SINKS TURNED ON BY THEMSELVES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT¿S BATTERY WAS REPLACED. THE PATIENT HAD GOOD COVERAGE, BUT MULTIPLE IMPEDANCE VALUES WERE OUT OF RANGE. THE OUT OF RANGE IMPEDANCE VALUES WERE ON ELECTRODES 2, 6, 8, 9, AND 13 AND PERSISTED WITH THE NEW BATTERY. THE PHYSICIAN ELECTED NOT TO REPLACE THE LEAD. THE PATIENT WAS NOT USING ANY OF THE CONTACTS THAT WERE OUT OF RANGE. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS REPORTED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. CHRONIC PAIN WAS NOTED AS PATIENT MEDICAL HISTORY. REFER TO MANUFACTURER REPORT # 3004209178-2017-03988 FOR THE REPORT OF THE IMPEDANCE ISSUE WITH THE PATIENT¿S NEW INS.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP), REPORTED THAT THE CAUSE OF THE EVENT WAS ¿PAIN¿. IT WAS ALSO REPORTED THAT IMPEDANCES OF >1000 WERE SEEN. AN X-RAY WAS TAKEN ON (B)(6) 2013 (NO RESULTS REPORTED). ON (B)(6) 2013, REPROGRAMMING WAS PERFORMED WITH GOOD RESULTS. NO HOSPITALIZATION WAS REQUIRED FOR THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114640 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