BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1083096 · Received July 24, 2008

    Report

    Report Number
    6000032-2008-04339
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MDT PUERTO RICO OPERAITONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATION SYSTEM WAS REMOVED DUE TO A LACK OF EFFICACY. THE PATIENT STATED, "HE NEVER HAD MUCH RELIEF FROM THE STIMULATION AND RARELY USED IT". THE HCP NOTED ONE OF THE TWO QUAD LEADS HAD COMPLETELY DISLODGED FROM THE EPIDURAL SPACE AND WAS CURLED UP AROUND T12 WHERE IT HAD BEEN INSERTED. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER) USED TO DELIVER MORPHINE| EXTENSION MODEL 7495-10 LTO# NAH006700N| EXPLANTED:| EXTENSION MODEL 7495-10 LOT# NAH004531N| INTRATHECAL DRUG DELIVERY SYSTEM (PUMP AND