BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 5605502 · Received April 25, 2016

    Report

    Report Number
    3004209178-2016-08158
    Event Type
    Injury
    Date Received
    April 25, 2016
    Report Date
    April 25, 2016
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-33, LOT# V166106, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3487A-33, LOT# V092439, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE PATIENT VIA THE MANUFACTURER¿S REPRESENTATIVE REPORTED THEY WERE SEEN IN THE DOCTOR¿S OFFICE ON THE DAY OF REPORT FOR THEIR ¿PRP¿ APPOINTMENT. UPON INTERROGATION OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY AN IMPEDANCE CHECK WAS MADE AND EVERY ELECTRODE HAD HIGH IMPEDANCES. THE PATIENT STATED THAT THEY HAD NOT FELT ANY STIMULATION FOR 6 MONTHS. THE PATIENT THOUGHT THAT THEY MAY NEED TO HAVE THE LEADS REPLACED AND PUT OFF COMING INTO THE OFFICE OR CALLING THE REPRESENTATIVE. NO FALLS WERE REPORTED. NO INTERVENTIONS WERE PLANNED AT THE TIME OF REPORT. IT WAS NOTED THE PATIENT WAS A ¿PRP¿ FOR THEIR INS AND NEEDED IT REPLACED (SURGICAL INTERVENTION PLANNED BUT HAD NOT BEEN SCHEDULED). IF THE PHYSICIAN AGREES, THE LEADS WILL BE REPLACED AS WELL. THE ISSUE HAD NOT BEEN RESOLVED AT THE TIME OF REPORT AND THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. THE INDICATION FOR USE FOR THE IMPLANTED DEVICE WAS NOTED AS FAILED BACK SURGERY SYNDROME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259358 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention