BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3435034 · Received October 29, 2013

    Report

    Report Number
    3004209178-2013-19815
    Event Type
    Malfunction
    Date Received
    October 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3998, LOT# V013787, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3998, LOT# V013787, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL ON (B)(6) 2013 AND ¿WENT DOWN ON HER TAILBONE.¿ THE REPORTER STATED THAT SINCE THE FALL, THE PATIENT HAD HAD PAIN AT THE LEAD SITE. IT WAS REPORTED THAT THE PATIENT WAS VERY SORE AND COULD FEEL THE WIRES THROUGH HER SKIN. IT WAS NOTED, THE PATIENT WAS BARELY ABLE TO WALK DUE TO THE PAIN. IT WAS STATED, SOMETHING WAS NOT RIGHT WITH THE WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555596 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 00040 YR