BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 5534240 · Received March 30, 2016

    Report

    Report Number
    6000032-2016-00034
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    January 1, 2016
    Report Date
    May 16, 2016
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE INS WAS REPLACED ON (B)(6) 2016. PRIOR TO THE PROCEDURE THE IMPEDANCES WERE ¿OFF¿ AND GREATER THAN 40,000 AND THE PATIENT WAS NOT FEELING STIMULATION ON EITHER SIDE WHEN THE MANUFACTURER REPRESENTATIVE INCREASED THE AMPLITUDE. THE PATIENT HAD NOT BEEN FEELING STIMULATION FOR APPROXIMATELY 6 MONTHS AROUND 2016-03-28.

    Additional Manufacturer Narrative · 1

    (B)(6). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE CONSUMER HAD EXCELLENT COVERAGE UNTIL THE DEVICE STOPPED WORKING. AFTER THE DEVICE STOPPED WORKING IN (B)(6) THE CONSUMER EXPERIENCED A SUDDEN RETURN OF SYMPTOMS. IMPEDANCE MEASUREMENTS WERE TAKEN AT 3.5 VOLTS WITH RESULTS AS FOLLOWS: 0-1, 0-2, 0-3 WERE ALL 3,620, 0-4, 0-5, 0-6, 0-7 WERE ALL GREATER THAN 4,000, 1-3 WAS 3620, 1-2 WAS 3620, 1-4, 1-6, 1-7 WERE ALL GREATER THAN 4,000, 2-3 WAS 3260, AND ALL OTHER COMBINATIONS WERE GREATER THAN 4,000. THE CLINICIAN PROGRAMMER WAS USED WHICH SHOWED THE BATTERY CAPACITY USED WAS 88-100% AND ITS' STATUS WAS LOW. IT WAS NOTED THERE WERE NO RECENT TRAUMAS OR FALLS REPORTED THAT COULD BE RELATED TO THIS EVENT AND IT WAS UNKNOWN IF THERE WAS ANY RECENT MEDICAL TESTING OR EMI EXPOSURE. RELEVANT MEDICAL HISTORY INCLUDES RADICULAR PAIN SYNDROME (RADICULOPATHIES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191761 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention