BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3082730 · Received April 29, 2013

    Report

    Report Number
    6000032-2013-00108
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 12, 2013
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-33, LOT# J0519463V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE IMPEDANCE READINGS GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLAR PAIRS. IT WAS ALSO REPORTED THE PATIENT WAS NOT FEELING A STIMULATION SENSATION. IT WAS LATER REPORTED THAT THE PHYSICIAN MAY GET AN X-RAY OR EVALUATE THE OPTIONS BECAUSE THE PATIENT'S DEVICE MAY BE NEAR ITS END OF SERVICE (EOS). IT WAS ALSO STATED THE PATIENT WANTED MORE PAIN RELIEF AND WANTED TO MEET WITH THEIR HEALTHCARE PROVIDER TO EVALUATE OPTIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD INCREASED PAIN AND MINIMAL PAIN RELIEF. IT WAS NOTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185490 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1