BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3944831 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13257
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID 3998, LOT # J0437048V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS NOW RECEIVING EFFECTIVE THERAPY AFTER THEIR REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS DETERMINED THE BATTERY HAD DEPLETED NORMALLY. THE HEALTH CARE PROVIDER (HCP) PLANS TO REPLACE THE PATIENT¿S DEVICE DUE TO THE NORMAL BATTERY DEPLETION BUT PLANS TO LEAVE THE LEADS ALONE BECAUSE THE PATIENT WAS GETTING GOOD STIMULATION WITH THE LEADS THAT ARE IN PLACE AND THE PROGRAMS THEY HAVE. THE LAST TIME THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT THE VOLTAGE WAS 2.2V. NO OUTCOME WAS PROVIDED PERTAINING TO THE REPLACEMENT HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW THE FLASHING LOW LIGHT ON THE PATIENT PROGRAMMER. IT WAS UNKNOWN WHEN THE PATIENT STARTED SEEING THE BLINKING LOW LIGHT. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A LOW BATTERY OCCURRED. IT WAS NOTED THAT IMPEDANCE MEASUREMENTS WERE TAKEN AND THE MANUFACTURING REPRESENTATIVE WAS GETTING QUESTION MARKS IN RESULTS. IT WAS NOTED THAT THE PATIENT SAW THE PATIENT PROGRAMMER BATTERY FLASHING ABOUT 10 DAYS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT¿S STIMULATION HAD BEEN ON ALL DAY AND THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY VOLTAGE WAS 2.2V. IT WAS NOTED THAT THERE WERE ELECTRODES WITH ABNORMAL VALUES. IT WAS NOTED THAT ON CONTACT 0/4, IMPEDANCES OF GREATER THAN 4 ,000 OHMS WERE MEASURED. CONTACTS 1/4, 2/4, 3/4, AND 4/5 HAD IMPEDANCE VALUES OF 3,030OHMS. CONTACTS 0/7 AND 1/5 SHOWED ??? VALUES. IT WAS NOTED THAT THE PATIENT WAS NOT PROGRAMMED WITH ELECTRODE 0/4. THE PATIENT WAS GETTING APPROPRIATE STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S BATTERY REACHED THE ESTIMATED REPLACEMENT INDICATOR (ERI) AT AN UNKNOWN DATE. THE PATIENT¿S WIFE NOTICED THE LIGHT FLASHING ABOUT 2 WEEKS PRIOR TO THEIR APPOINTMENT WITH THE MANUFACTURING REPRESENTATIVE. THE DEVICE HAD NOT REACHED THE END OF SERVICE (EOS) AT THE TIME OF THE REPORT. THE DEVICE WOULD BE EXPLANTED AND REPLACED ON (B)(6) 2014. IT WAS UNKNOWN IF THE PATIENT¿S DEVICE WAS IN CYCLING OR CONTINUOUS MODE. THE PATIENT WAS DOING WELL AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422226 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention