BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2543168 · Received April 20, 2012

    Report

    Report Number
    6000032-2012-00033
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Report Date
    March 27, 2012
    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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL: 3887-33, LOT #: J0125363V, IMPLANTED: (B)(6) 2002, EXPLANTED: NA; EXTENSION MODEL: 7495LZ51, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2002, EXPLANTED: NA; PLUG/BOOT MODEL: 3550-09, LOT #: LA2114, IMPLANTED: (B)(6) 2002, EXPLANTED: NA; PROGRAMMER MODEL: 7435, SERIAL #: (B)(4); CONCOMITANT SYSTEM: INS MODEL: 37111, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA; LEAD MODEL: 377645, LOT #: V003613, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; LEAD MODEL: 377645, LOT #: V003613, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; EXTENSION MODEL: 3708120, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA; EXTENSION MODEL: 3708120, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA; PROGRAMMER MODEL: 37742, SERIAL #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) 'FAILED'. IT WAS NOTED THAT THE PATIENT RECEIVED A NEW INS SYSTEM A YEAR LATER WHICH ALSO 'FAILED', BUT NO ACTIONS WERE TAKEN TO REMEDY THE SITUATION. THE PATIENT EXPERIENCED PAIN IN HIS HIP AND AT THE LEAD SITE NEAR HIS SPINE AND WANTED THE SECOND SYSTEM REMOVED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SEE MANUFACTURER'S REPORT #3004209178-2012-02536 FOR THE SUBSEQUENT INS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1