BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2100656 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03582
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    August 13, 2007
    Report Date
    April 12, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE EVENT DATE WAS (B)(6) 2007. INTERROGATION OF THE DEVICE RESULTED IN POSSIBLE CONNECTION ISSUES. IT WAS NOTED THAT THIS WAS NOT VERIFIED DURING FOLLOW UP. THE PHYSICIAN STATED THE JOLTING SENSATION WAS MOST LIKELY DUE TO CONNECTION ISSUES. THE EVENT WAS NOTED AS RELATED TO THE DEVICE OR THERAPY AND UNLIKELY RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THERE WERE GENERATOR CONNECTION ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT NOTICED "SOME" JOLTING SENSATION AROUND THE STIMULATOR SITE AND IN THE BACK. THE PT ALSO HAD PAIN IN THE BACK AND LEG. THE STIMULATOR WAS INTERROGATED, AND THE BATTERY WAS DEPLETED. A FEW DAYS LATER, THE STIMULATOR WAS REPLACED, AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# J0443899V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU115276V