BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2541692 · Received April 19, 2012

    Report

    Report Number
    3004209178-2012-02503
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Report Date
    March 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL: 3986A, LOT#: N182431, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD MODEL: 3986A, LOT#: N179496, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION MODEL: 748966, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION MODEL: 748966, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: NA. PROGRAMMER MODEL: 7435, SERIAL#: (B)(4). (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED PATIENT WAS TO HAVE THE TOTAL INS SYSTEM EXPLANTED AT A YET TO BE DETERMINED DATE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT AFTER SHE FELL "A FEW MONTHS AGO." THE IMPEDANCE VALUES MEASURED WERE HIGHER THAN AVERAGE, BUT STILL WITHIN THE NORMAL RANGES. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED IMPEDANCES WERE ALSO MEASURED <(><<)>250 OHMS AND THAT THE COMPANY REPRESENTATIVE AND PROGRAMMED AROUND IT. A REVISION OF THE OCCIPITAL LEADS WAS PLANNED IN 2-3 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    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