BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2223854 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06559
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 28, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED AN ACUTE INCIDENT WHERE THE STIMULATION "WENT CRAZY" AND SHE EXPERIENCED INTENSE SHOCKING AND PAIN FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) WHICH RESULTED IN A LOSS OF THERAPY. THE INTENDED THERAPY FOR THE PT WAS PERIPHERAL NERVE STIMULATION. TWO ON-POINT LEADS HAD BEEN PLACED ON THE RADIAL NERVE. PT REQUIRED VERY LITTLE CHANGES TO PROGRAMMING AND/OR SETTINGS. [2 PROGRAMS = PROGRAM 1: AMP: 0.35, PULSE WIDTH: 180, RATE: 80, ELECTRODE SETTINGS: 0(+) AND 2(-);PROGRAM 2: AMP: 0.35, PULSE WIDTH: 180, RATE: 80, ELECTRODE SETTINGS: 6(+) AND 7(-)]. FOLLOWING THE ACUTE INCIDENT, THE PT REPORTED THAT SHE COULD NO LONGER USE THE INS WITHOUT HAVING A REPEAT OCCURRENCE OF THE EVENT. REPROGRAMMING WAS ATTEMPTED WITH THE SAME RESULT. IT WAS REPORTED THAT THE PT HAD BEEN WITHOUT STIMULATION FOR SEVERAL MONTHS BECAUSE SHE COULD NOT USE IT WITHOUT INTENSE INCREASE IN STIMULATION. THE INS WAS EXPLANTED. PT REQUIRED VERY LITTLE CHANGES TO PROGRAMMING AND/OR SETTINGS. TWO PROGRAMS WERE UPDATED ON THE INS. INTRA-OPERATIVE IMPEDANCE MEASUREMENTS WERE TAKEN AND THE RESULTS WITHIN THE NORMAL RANGE OF 300-1000 OHMS. PT HAD NO INJURIES RELATED TO THE INCIDENT AND RECOVERED WITHOUT SEQUELA. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU162089V| LOT# *UK6157159| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU162090V| UNK CONVERSION TYPE: MODEL LEADN| LOT# *UK6157160| EXPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN| IMPLANTED:| EXPLANTED: