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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
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
Report NumberMW5072487
Device Sequence Number1
Product CodeFTR
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 NO INFORMATION
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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