BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3935011 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13020
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 20, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3587A, LOT# N0026949, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495LZ66, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7495LZ66, SERIAL# (B)(4), IMPLANTED: 2002 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3587A, LOT# N0028934, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3587A, LOT# N0026949, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3587A, LOT# N0028934, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT NOTICED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY HAD GONE DEAD ¿A COUPLE WEEKS¿ AGO. IT WAS REPORTED, THE PATIENT STATED ¿IT¿S ABOUT THAT TIME¿ BECAUSE, THE DEVICE WAS IMPLANTED IN 2008 AND THE ¿LAST ONE WAS THE SAME WAY¿. IT WAS REPORTED, THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS FURTHER NOTED, THE PATIENT NEEDED AN MRI OF THEIR KNEE BUT IT WAS NOT RELATED TO THEIR PAIN STIMULATOR. IT WAS FURTHER REPORTED A LONGEVITY CALCULATION WAS PERFORMED. IT WAS NOTED, THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS AT 2.64V (35/70%). PROGRAM 1: 2 ANODES AND 1 CATHODE AT 1.2V/250PW/40HZ AND PROGRAM 2: 2 ANODES AND 1 CATHODE AT 0.8V/250PW/40HZ. IT WAS NOTED THAT WHEN ON FOR 15 HOURS USING 5.50 OHMS AND THE ESTIMATED LONGEVITY WAS >120 MONTHS. IT WAS FURTHER REPORTED, THE PATIENT¿S STIMULATION WAS INTERMITTENT AND CUTS OFF WHEN THEY MOVE THEIR HEAD TO EITHER THE RIGHT OR THE LEFT. IT WAS NOTED THIS HAS BEEN OCCURRING FOR SEVERAL MONTHS. IT WAS NOTED AN IMPEDANCE TEST WAS PERFORMED WITH READINGS RANGING FROM 470-690 OHMS AND ??? VALUES WERE SEEN WHEN THE PATIENT TURNED LEFT, RIGHT OR LOOKING STRAIGHT AHEAD. IT WAS REPORTED THE ??? SHOWED ON ELECTRODES 3-6. IT WAS NOTED THAT DURING THE IMPEDANCE TEST THE MOST THE PATIENT COULD TOLERATE WAS 0.7V AS 0.8V WAS TOO STRONG ON ONE OF THE LEADS. IT WAS REPORTED, THE HEALTH CARE PROVIDER (HCP) WANTED TO REPLACE A LEAD BECAUSE, IT LOOKS LIKE IT¿S POSSIBLY ROTATED BUT NO APPOINTMENT WAS SCHEDULED. ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT WAS SEEN IN THE CLINIC AND IT WAS FOUND THE BATTERY IS ¿STILL OK FOR VOLTAGE¿. IT WAS NOTED, THE PATIENT HAS INTERMITTENT STIMULATION WHEN THEY TURN THEIR HEAD. IT WAS NOTED, THEY WERE REPROGRAMMED FOR BETTER COVERAGE IN THE HAND AND LESS IN THEIR HAND. IT WAS NOTED, THE PATIENT IS GOING TO BE SCHEDULED FOR A REVISION OF THEIR LEADS AND TO BE CHANGED TO A RECHARGEABLE BATTERY BUT NO DATE HAD BEEN SET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THEIR LEAD REVISION ON 2014-(B)(6) AND IT WENT WELL. AT THEIR FIRST POST-OPERATION APPOINTMENT THE PATIENT WAS GETTING GOOD COVERAGE AND WAS HAPPY WITH THEIR STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412741 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention