MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

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.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6897697
• MDR Text Key: 87625417
• Report Number: MW5072487
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 61