BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1213787 · Received October 22, 2008

    Report

    Report Number
    6000032-2008-06734
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO. MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD NO STIMULATION SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS. THE PT SYMPTOMS WERE AT THE PARESTHESIA AREA. THE PT WAS AT HOME AND HER STATUS WAS GOOD. THE PROGRAMMER WAS RESET. THE PROGRAMMER INDICATED THE DEVICE WAS ON. THE PT WAS INCREASING THE STIMULATION, BUT DID NOT FEEL ANY STIMULATION AT ALL. THE PT WAS ENCOURAGED TO CONTACT HER HEALTHCARE PROFESSIONAL. IMPEDANCES WERE EVALUATED AND READINGS OF >4,000 OHMS WERE FOUND ON ALL OR SOME OF THE UNIPOLAR PAIRS AND MANY OF THE BIPOLAR PAIRS. THE AMPLITUDE WAS INCREASED TO OBTAIN PAIN CONTROL. ADDITIONAL TROUBLESHOOTING WAS RECOMMENDED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO. MED REL 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention EXTENSION: MODEL 7489 LOT# NHU069571V| EXPLANTED:| LEAD: MODEL 3998| PROGRAMMER: MODEL 7435| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489