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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS
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MENTOR BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Fatigue (1849); Tachycardia (2095); Thyroid Problems (2102)
Event Date 09/15/2013
Event Type  Injury  
Event Description
This is the date of my first cardiac ablation for persistent premature ventricular contractions (pvc). It is one of 2 ablations in less than a year. It is related to my breast implants in my opinion. Mainly because shortly after getting the implants in 2004, i started experiencing rapid heart rate which was eventually controlled with beta blockers, but then i started having pvc's more frequently and not always controlled by medication. I started having sensitivity to foods which i never had before and the foods cause pvc's. I was diagnosed with hashimoto's thyroiditis 3 years ago. I am tired all the time despite excellent diet and plenty of exercise. I experience brain fog, trouble recalling words and i'm only(b)(6). I am cold all the time and my hormones are poorly balanced on their own.
 
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Brand NameBREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6897697
MDR Text Key87625417
Report NumberMW5072487
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/25/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/27/2017 Patient Sequence Number: 1
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