BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3965020 · Received July 29, 2014

    Report

    Report Number
    6000032-2014-00152
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # LB7836, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE WAS NOT WORKING AND THE IMPLANTABLE NEUROSTIMULATOR (INS) NEEDED TO BE CHECKED. IT WAS NOTED THE PATIENT HAD THE INS CHECKED A FEW MONTHS AGO BY A MANUFACTURING REPRESENTATIVE. THE REPORTER STATED THEY WERE TOLD THEY NEED TO SEE THEIR HEALTHCARE PROFESSIONAL (HCP) FOR THE DEVICE. THE REPORTER FURTHER STATED THE INS WAS NOT WORKING AND THEY DID NOT FEEL STIMULATION. IT WAS NOTED THE PATIENT REPLACED THE BATTERIES IN THE PROGRAMMER, BUT THE PROGRAMMER WAS NOT WORKING. IT WAS FURTHER NOTED THE PATIENT WANTED TO KNOW IF THEY COULD HAVE AN MRI FOR THEIR SHOULDER. IT WAS NOTED THE MRI WAS NOT RELATED TO THE PATIENT¿S THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT THEY HAD NOT SOUGHT FURTHER HELP. THE REPORTER STATED THEY NEED INFORMATION AND WANTED TO KNOW IF THEY COULD HAVE AN MRI OF THEIR SHOULDER. THE REPORTER FURTHER STATED THEIR STIMULATION WAS NOT WORKING. IT WAS NOTED THE PATIENT HAD NOT SEEN A HEALTHCARE PROFESSIONAL (HCP) IN A LONG TIME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THE DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP. IT WAS FURTHER NOTED THAT THE PATIENT WAS HAVING TROUBLE GETTING AN APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441124 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR