BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRU

    MDR report key: 8524566 · Received April 17, 2019

    Report

    Report Number
    3004209178-2019-07678
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 2, 2019
    Report Date
    October 7, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761088
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVENT DATE APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTING THAT IT WAS NOT DISCOVERED VIA X-RAY, IT WAS REPORTED TO FAMILY BY THE NEUROSURGEON. THE SYSTEM HAS BEEN REPEATEDLY CHECKED FOR IMPEDANCES. ALL THERAPEUTIC LEAD IN VIE HAVE HAD NORMAL IMPEDANCES. HOWEVER, PATIENT CONTINUES TO COMPLAIN INCONSISTENTLY AND INTERMITTENTLY. THE NEUROSURGEON HAS AGREED TO CHANGE OUT THE EXTENSION WIRES. OPERATION DATE IS PENDING. THE ISSUE IS NOT YET RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER INDICATING THE PATIENT WAS EXPERIENCING CHEST PAIN SURROUNDING WHERE THE INS' ARE PLACED AND IT WAS GREATER ON THE RIGHT SIDE THAN THE LEFT SIDE. THEY DESCRIBED IT AS A BURNING, SHARP SENSATION THAT EVEN CAUSES FOOT PAIN. THE PATIENT CRIES AND BALLS DUE TO THE PAIN. THEY COULDN'T EVEN STAND UP LONG ENOUGH TO DO A DANCE OR THEIR VOCALS. THE CALLER STATED THE PATIENT WENT TO THE DOCTOR (HCP) AND A CURRENT LEAK WAS DISCOVERED BY X-RAY ON THE RIGHT SIDE BUT THE HCP TOLD THE CALLER TO KEEP A LOG OF THE PATIENT'S PAIN AND GO HOME BECAUSE THEY WOULD BE FINE. THEY CHECKED THE CURRENT LEAK TWICE, THEN CALLED A COUPLE DAYS LATER SAYING THERE WAS NOTHING WRONG WITH THE PATIENT. THE CALLER STATED A CURRENT LEAK CAN'T BE CHECKED ON AN X-RAY AND THE PATIENT WAS NOT FINE. THEY HAVE TO TURN THE DEVICES OFF FOR THE CHEST PAIN TO GO AWAY AND IT HELPS BY 90%, BUT WHEN THE DEVICE IS OFF THEY EXPERIENCE DYSTONIA. IT WAS SUGGESTED FOR THE CALLER TO FOLLOW-UP WITH HCP TO DISCUSS SYMPTOMS AND THE INS STATUS. REFER TO MANUFACTURER REPORT #3004209178-2019-04879 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315848 MRU STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761088

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention