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

Model Number ESS305

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Seizures (2063); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain,'), seizure ('seizures') and epilepsy ('epilepsy') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not underwent for essure confirmation test".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure (seriousness criterion medically significant), epilepsy (seriousness criterion medically significant), fatigue ("fatigue."), vaginal infection ("infection (bladder/ urinary tract/vaginal) type: unknown"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: unknown"), female sexual dysfunction ("apareunia"), mental disorder ("psychological or psychiatric problems, condition: unknown"), cystitis ("infection (bladder/ urinary tract/vaginal) type: unknown"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia") and endometriosis ("endometriosis").The patient was treated with surgery (bilateral oophorectomy - removal of tubes).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, seizure, epilepsy, fatigue, vaginal infection, urinary tract infection, female sexual dysfunction, mental disorder, cystitis, dysmenorrhoea, dyspareunia and endometriosis outcome was unknown.The reporter considered cystitis, dysmenorrhoea, dyspareunia, endometriosis, epilepsy, fatigue, female sexual dysfunction, mental disorder, pelvic pain, seizure, urinary tract infection and vaginal infection to be related to essure.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain, endometriosis, epilepsy, seizure, dysmenorrhea, fatigue.Most recent follow-up information incorporated above includes: on 1-jul-2019: pfs and mr received : event injury nos is replaced with pelvic pain.Reporter added, essure removal date added, product indication updated.Events added- pelvic pain, bladder infection, uti, vaginal infection, apareunia (inability to have sexual intercourse),psychological disorder, seizures, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, epilepsy, endometriosis, device monitoring procedure not performed.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformance's data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain,'), seizure ('seizures') and epilepsy ('epilepsy') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not underwent for essure confirmation test".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure (seriousness criterion medically significant), epilepsy (seriousness criterion medically significant), fatigue ("fatigue."), vaginal infection ("infection (bladder/ urinary tract/vaginal) type: unknown"), urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: unknown"), female sexual dysfunction ("apareunia"), mental disorder ("psychological or psychiatric problems condition: unknown"), cystitis ("infection (bladder/ urinary tract/vaginal) type: unknown"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), endometriosis ("endometrosis") and abdominal pain ("abdominal pain") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy (full),bilateral oophorectomy - removal of tubes).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, seizure, epilepsy, fatigue, vaginal infection, urinary tract infection, female sexual dysfunction, mental disorder, cystitis, dysmenorrhoea, dyspareunia, endometriosis, abdominal pain and hormone level abnormal outcome was unknown.The reporter considered abdominal pain, cystitis, dysmenorrhoea, dyspareunia, endometriosis, epilepsy, fatigue, female sexual dysfunction, hormone level abnormal, mental disorder, pelvic pain, seizure, urinary tract infection and vaginal infection to be related to essure.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain, endometriosis, epilepsy, seizure, dysmenorrhea, fatigue.Most recent follow-up information incorporated above includes: on 9-sep-2019: pfs received: new events abdominal pain, hormonal changes were added.Reporter was added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain,') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not underwent for essure confirmation test".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure ("seizures"), epilepsy ("epilepsy"), fatigue ("fatigue."), vaginal infection ("infection (bladder/ urinarytract/vaginal) type: unknown"), urinary tract infection ("infection (bladder/ urinarytract/vaginal) type: unknown"), female sexual dysfunction ("apareunia"), anxiety ("anxiety"), cystitis ("infection (bladder/ urinarytract/vaginal) type: unknown"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), endometriosis ("endometrosis"), abdominal pain ("abdominal pain"), depression ("depression") and vulvovaginal pain ("vaginal pain") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy (full),bilateral oophorectomy - removal of tubes).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, epilepsy, fatigue, vaginal infection, urinary tract infection, female sexual dysfunction, cystitis, dysmenorrhoea, dyspareunia, endometriosis and hormone level abnormal outcome was unknown and the seizure, anxiety, abdominal pain, depression and vulvovaginal pain was resolving.The reporter considered abdominal pain, anxiety, cystitis, depression, dysmenorrhoea, dyspareunia, endometriosis, epilepsy, fatigue, female sexual dysfunction, hormone level abnormal, pelvic pain, seizure, urinary tract infection, vaginal infection and vulvovaginal pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: one tube was block and placed correctly; the other side was incorrectly placed.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain, endometriosis, epilepsy, seizure, dysmenorrhea, fatigue.Most recent follow-up information incorporated above includes: on 28-feb-2020: pfs received: new events- vaginal pain, depression was added & one event was updated from to psyche injury to anxiety.Event outcomes were added.Lab test was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain,') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not underwent for essure confirmation test".On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), seizure ("seizures"), epilepsy ("epilepsy"), fatigue ("fatigue."), vaginal infection ("infection (bladder/ urinarytract/vaginal) type: unknown"), urinary tract infection ("infection (bladder/ urinarytract/vaginal) type: unknown"), female sexual dysfunction ("apareunia"), anxiety ("anxiety"), cystitis ("infection (bladder/ urinarytract/vaginal) type: unknown"), dysmenorrhoea ("dysmenorrhea"), dyspareunia ("dyspareunia"), endometriosis ("endometrosis"), abdominal pain ("abdominal pain"), depression ("depression") and vulvovaginal pain ("vaginal pain") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (hysterectomy (full),bilateral oophorectomy - removal of tubes).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, epilepsy, fatigue, vaginal infection, urinary tract infection, female sexual dysfunction, cystitis, dysmenorrhoea, dyspareunia, endometriosis and hormone level abnormal outcome was unknown and the seizure, anxiety, abdominal pain, depression and vulvovaginal pain was resolving.The reporter considered abdominal pain, anxiety, cystitis, depression, dysmenorrhoea, dyspareunia, endometriosis, epilepsy, fatigue, female sexual dysfunction, hormone level abnormal, pelvic pain, seizure, urinary tract infection, vaginal infection and vulvovaginal pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: one tube was block and placed correctly; the other side was incorrectly placed.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain, endometriosis, epilepsy, seizure, dysmenorrhea, fatigue.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality-safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary 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: 8766843
• MDR Text Key: 150248735
• Report Number: 2951250-2019-03436
• 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: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2020

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
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 09/09/2019; 02/28/2020
• Supplement Dates FDA Received: 09/23/2019; 03/16/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention