MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Weakness (2145); Myalgia (2238)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 23-jul-2018.This spontaneous case was reported by an other health professional and describes the occurrence of migraine ("migraine"), myalgia ("myalgia") and asthenia ("asthenia") in a female patient who had essure inserted.In 2012, the patient had essure inserted.On an unknown date, 6 years 6 months after insertion of essure, the patient experienced migraine (seriousness criteria medically significant and intervention required), myalgia (seriousness criteria medically significant and intervention required) and asthenia (seriousness criteria medically significant and intervention required).The patient was treated with surgery (essure removal via laparoscopic total bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the migraine, myalgia and asthenia outcome was unknown.The reporter considered asthenia, migraine and myalgia to be related to essure.The reporter commented: patient wished removal of essure due to migraines, myalgia and asthenia.Diagnostic results: laparoscopy - on (b)(6) 2017: integrity of fallopian tubes, no effraction of the implants.Incident.No lot number or sample was 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 in a supplemental report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 23-jul-2018.The most recent information was received on 16-aug-2018.This spontaneous case was reported by an other health professional and describes the occurrence of migraine ("migraine"), myalgia ("myalgia") and asthenia ("asthenia") in a female patient who had essure inserted.In 2012, the patient had essure inserted.On an unknown date, 6 years 6 months after insertion of essure, the patient experienced migraine (seriousness criteria medically significant and intervention required), myalgia (seriousness criteria medically significant and intervention required) and asthenia (seriousness criteria medically significant and intervention required).The patient was treated with surgery (essure removal via laparoscopic total bilateral salpingectomy), surgery (essure removal via laparoscopic total bilateral salpingectomy) and surgery (essure removal via laparoscopic total bilateral salpingectomy).Essure was removed on (b)(6)2018.At the time of the report, the migraine, myalgia and asthenia outcome was unknown.The reporter considered asthenia, migraine and myalgia to be related to essure.The reporter commented: patient wished removal of essure due to migraines, myalgia and asthenia.Diagnostic results: laparoscopy - on (b)(6)2017: integrity of fallopian tubes, no effraction of the implants.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-aug-2018: quality-safety evaluation of ptc.Incident: no lot number or sample was 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 in a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7721929
• MDR Text Key: 115081952
• Report Number: 2951250-2018-03214
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention