MAUDE Adverse Event Report: MEDTRONIC REVEAL LINQ INSERTABLE CARDIAC MONITOR ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Atrial Fibrillation (1729); Breast Cancer (1759); Pain (1994); Respiratory Distress (2045); Tachycardia (2095); Weakness (2145); Ambulation Difficulties (2544)

Event Date 12/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, i was diagnosed with stage iv metastatic adenocarcinoma of the left breast, and had been created beginning on (b)(6) 2019 with ibrance, 75mg.For 21 days and letrozole, 2.5mg for 28 days.Both were in addition, losartan, 25mg.Was discontinued on (b)(6) 2019.Per the recommendation of the fda, on (b)(6) 2019 the losartan prescription had been filled by (b)(6), from: (b)(6) bk:45 qty:90.Pharmacist: (b)(6).On (b)(6) 2019, (b)(6) drugs refilled the losartan, 25mg.Prescription form; hetero drug ltd.Bk: 5, qty: 90.Pharmacist: (b)(6).This losartan was bitter.On (b)(6) 2019, i had mentioned to (b)(6) the increase in nosebleeds requiring cauterization, weaknesses, heavy mucous, uncontrollable coughing and difficulty balancing.She recommended that i call my primary care physician for a similar medication, which i did on (b)(6) 2019.Telmisartan was prescribed which also had to be discontinued.Mention was also made of the (b)(6) 2019 appointment with dr (b)(6) for removal of stitches following the (b)(6) 2018 implant of the medtronic loop ling recorder in my left breast.Because i was so ill, dr (b)(6) said he couldn't proceed, because i was shaking, coughing and could barely walk.However, he did wait and, because i couldn't climb up on the examining table, he removed the stitches while i sat in the chair.It had never occurred to me that perhaps the new bitter losartan from hetero drug ltd in (b)(6) might have been the causal factor ¿ ((b)(6) 2019).Prior to losartan, i had taken losartan for three years and 8 months before its recall, because it continued rocket fuel a caregiver.The outside limit for ca19-9 is 35, mine had escalated to 160, but lab tests were discontinued, when on (b)(6) 2019, the diagnosis was stage iv metastatic adenocarcinoma of the left breast and their lab test took precedence.Thank you for evaluating the hetero drug ltd.Losartan.I still am in the process of securing x-ray and ct scan records and regret the delay in completing these forms for you.Your diligence in analyses of medicines, devices and numerous substances and their recall if injurious, remains deeply appreciated by all whose lives you so devotedly protect.In 1992, i had a quadrantectomy of the left breast because of ductal carcinoma in sites, treated with radiation and tamoxifen, without recurrence.On (b)(6) 2018, cardiologist (b)(6) implanted a medtronic loop ling recorder in my left breast.He later stated the readings had shown atrial fibrillation and i was placed on eliquis.However, the same recordings, read by my current cardiologist, dr (b)(6), revealed the episodes were tachycardic, not atrial fibrillation.Because mammography could no longer be performed, my breast cancer surgeon, dr (b)(6), planned to remove the recorder on (b)(6) 2019.But, adjacent to the implant, there appeared a low, pea-sized growth, which dr (b)(6) excised.The (b)(6) biopsy report revealed stage iv metastatic adenocarcinoma of the left breast.Previously, on (b)(6) 2018 ultrasound was normal.Fortunately, the cancer was confined to the chest wall.Confirmed and pelvis.Having been cured of ductal carcinoma in sites in 1992 and, after having had the medtronic loop ling recorder implanted , and after having x-rays and ct scans of the chest after the implant, i now, at the age of (b)(6) with stage iv metastatic adenocarcinoma of the left breast, wonder if the implant might have been a caused factor in stage iv metastatic carcinoma in (b)(6) 2019, especially since the (b)(6) 2018 ultrasound was negative.I had been informed that the implant was made of polyurethane.However, upon removal, it was of metal.Do you know what the 5 gray exposure limit, or the ct scan limit in for repeated x-rays and ct scans of the chest with regard to the implant? any information you might provide would be greatly appreciated.I am still in the process of recurring x-ray and ct scan reports and apologize for the delay.Many thanks for your interest in, and addressing, the medical concerns of all who rely upon you for help.Please be advised that there are two topics: losartan and medtronic reveal linq insertable cardiac monitor.I apologize for the delay in forwarding these forms to you, but am still in the process of securing laboratory, x-ray and ct scans, which you require.Sincerely, (b)(6).

• Brand Name: REVEAL LINQ INSERTABLE CARDIAC MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 9804973
• MDR Text Key: 183530337
• Report Number: MW5093592
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LNQ11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 87 YR
• Patient Weight: 62