BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4112915 · Received September 24, 2014

    Report

    Report Number
    6000032-2014-00218
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    August 29, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-09, LOT # L98575, PRODUCT TYPE ACCESSORY; PRODUCT ID 7495-25, SERIAL # (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 3487A, LOT # J0104254V, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEY HAD A NON-FUNCTIONING UNIT REMOVED AND REPLACED. INFORMATION OMITTED PERTAINING TO EVENTS (B)(4)¿ PUMP ISSUE AND (B)(4)¿ NON-FUNCTIONING UNIT. THESE EVENTS ARE NOT RELATED, NO CAUSE OF THE EVENT WAS PROVIDED HOWEVER ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596074 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention