BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3984230 · Received August 6, 2014

    Report

    Report Number
    6000032-2014-00159
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT# LB7646, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD A LEAD CHANGE AND IT ¿WAS VERY PAINFUL.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED BUT IT WAS NOT DEVICE RELATED. THE PATIENT EXPERIENCED POST-SURGICAL PAIN. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS NOTED THE PATIENT NEVER SHOWED UP FOR HIS FOLLOW-UP APPOINTMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461109 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention