BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3833353 · Received May 27, 2014

    Report

    Report Number
    6000032-2014-00107
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3887-33, LOT# J0222915V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-33, LOT# J0222915V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED LONGEVITY CALCULATIONS SHOWED FIVE YEARS. IT WAS NOTED THE PATIENT¿S STIMULATOR WAS PROBABLY LASTING LONGER DUE TO HIGH IMPEDANCES. IT WAS REPORTED SOME CONTACT COMBINATIONS HAD IMPEDANCES GREATER THAN 4,000 OHMS. IT WAS NOTED THE PATIENT HAD GREAT COVERAGE, GOOD THERAPY, AND DID NOT COMPLAIN OF ANY ISSUES. IT WAS REPORTED THE PATIENT HAD NO FALLS OR TRAUMA ASSOCIATED WITH THE ISSUE. IT WAS NOTED THE START DATE OF THE HIGH IMPEDANCES WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310915 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR