MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Tinnitus (2103); Vertigo (2134); Vomiting (2144); Myalgia (2238); Arthralgia (2355); Lethargy (2560)

Event Date 05/15/2017

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 24-jul-2017.This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("essure removal") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2017, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced arthralgia ("joint pain"), myalgia ("muscle pain"), migraine ("severe migraines"), fatigue ("crushing fatigue"), vertigo ("vertigo"), vomiting ("vomiting"), lethargy ("lethargic state") and tinnitus ("tinnitus").Essure was removed on (b)(6) 2017.At the time of the report, the medical device removal, arthralgia, myalgia, migraine, fatigue, vertigo, vomiting, lethargy and tinnitus outcome was unknown.The reporter considered arthralgia, fatigue, lethargy, medical device removal, migraine, myalgia, tinnitus, vertigo and vomiting to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was (b)(6).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 25-jul-2017 for the following meddra preferred term: medical device removal.The analysis in the global safety database revealed 680 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the regulatory authority is not possible.Incident.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; mullerstr 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; mullerstr 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd; whippany, NJ 07981
• MDR Report Key: 6770621
• MDR Text Key: 81936586
• Report Number: 2951250-2017-02779
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2017

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?: No
• Device Operator: Physician
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 86