BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 5829020 · Received July 28, 2016

    Report

    Report Number
    3004209178-2016-15089
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    July 15, 2016
    Report Date
    October 20, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 · 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. 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

    THIS PRODUCT WAS USED FOR AN OFF-LABEL USE. THE INDICATION WAS FOR EZW. 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

    ADDITIONAL REVIEW INDICATED THAT THE INFORMATION REPORTED IN MFG REPORT # 3004209178-2018-22932 PERTAINS TO THIS EVENT. ANY ADDITIONAL INFORMATION WILL BE REPORTED IN THIS 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED AN INJURY DUE TO REPROGRAMMING AND SETTING THE STIMULATION TOO HIGH BY THE MANUFACTURER REPRESENTATIVE. IT WAS STATED THEY HAD A BRUISE THE DAY AFTER PROGRAMMING AFTER THEY WOKE UP. THE BRUISE WAS ALL THE WAY FROM THEIR BACK TO THEIR SIDE AND IT HURT REALLY BADLY. IT WAS STATED THERE WAS A RECENT MEDICAL TEST OR ELECTROMAGNETIC INTERFERENCE (EMI) ENVIRONMENTAL EXPOSURE WHERE THE PATIENT HAD HEMORRHOID SURGERY 5 MONTHS AGO, BUT LATER SAID OCTOBER OF LAST YEAR. UNCLEAR WHEN THE SURGERY TOOK PLACE. IT WAS MENTIONED THEY HAD ASPIRATION PNEUMONIA FOR 3 WEEKS. THE PATIENT INDICATED THEY HAD REPROGRAMMING ON (B)(6) 2016 AND THE MANUFACTURER REPRESENTATIVE TURNED IT UP REALLY HIGH. THEY SAID IT HURT REALLY BADLY SO THEY TURNED IT BACK DOWN WHEN THEY GOT HOME. SINCE THEN, IT HAD BEEN SOFTER SO THEY TURNED IT UP 2 BEEPS. THE PATIENT HAD BEEN TRYING TO GET A HOLD OF THEIR DOCTOR. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FOR THEIR BOWELS SINCE THEY DIDN'T HAVE MUCH OF LOWER BOWEL AND USED MOST OF IT FOR THEIR INDIANA POUCH. THEY SAID THEY DIDN'T HAVE A BLADDER OR PROSTRATE SO THE USED THE INS MAINLY FOR PELVIC FLOOR DYSFUNCTION TO HOLD ONTO THEIR POOP. IT WAS NOTED THAT THEY USED MOST OF THE BOWEL TO BUILD THE INDIANA POUCH FOR THEIR BLADDER AND THEY COULD FEEL HOW MUCH THEY HAD IN THEIR BLADDER SO THEY DIDN'T OVERFILL THEIR NEW BLADDER. THE STATED THAT IF STIMULATION WAS ENOUGH, THEY DIDN'T POOP ON THEMSELVES, BUT IF THEY TURNED IT OFF, THEY POOPED IN THEIR UNDERWEAR AND DOWN THEIR LEG IF THEY HAD DIARRHEA. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE TOLD THEM THAT THEY HAD 20% OF THEIR INS BATTERY LEFT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S STIMULATION WAS TURNED UP HIGH BECAUSE THEY WERE NOT FEELING IT. THE PATIENT ALSO STATED THAT WHEN STIMULATION WAS TURNED UP HIGH "IT BURNED UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483255 SYNERGY VERSITREL STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other