BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 2626320 · Received June 22, 2012

    Report

    Report Number
    3004209178-2012-04776
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Report Date
    May 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3889-28, LOT# V022884, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# V039330, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION THAT WAS DESCRIBED AS "PAINFUL", FOLLOWING ELECTROMAGNETIC INTERFERENCE EXPOSURE, IN THE FORM OF CARDIAC RF ABLATION. THE OVERSTIMULATION SENSATION WAS PRESENT AT THE AREA OF PARESTHESIA. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1