BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2857899 · Received December 5, 2012

    Report

    Report Number
    3004209178-2012-11181
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Report Date
    November 12, 2012
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748966, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # V001984, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT # V006281, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD FEEL STIMULATION FROM THE LEFT ELECTRODE BUT COULD NOT FEEL STIMULATION FROM THE RIGHT ELECTRODE. PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF FOR TWO WEEKS AND HAD JUST NOTICED THE STIMULATION PROBLEM. PATIENT WANTED TO KNOW IF THEY SHOULD SEE THEIR DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WENT TO HER HEALTH CARE PROVIDER AND THE DEVICE WAS INTERROGATED WITH A CLINICIAN PROGRAMMER. IT WAS SEEN THAT ONE OF THE CONTACTS WAS NOT WORKING. THE DEVICE WAS REPROGRAMMED AROUND THE CONTACT AND THE PATIENT WAS NOW RECEIVING COVERAGE "JUST FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1