MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) regarding a patient receiving remodulin (unknown dose and concentration) via an implantable pump.It was reported there was a device malfunction where the expected residual volume was 9.2 ml and the actual residual volume was 17.9ml.The pump accuracy was 72% and the flow rate was outside the expected range.The patient reported no symptoms and there was no impact to the patient.There was no additional medical intervention required to prevent permanent injury or impairment and no action was taken.No assessment for product/therapy/procedure relatedness was performed.The patient's medical history included dyspnea / shortness of breath - on exertion, exercise intolerance, palpitations, orthopnea, congenital heart disease, hypertension, pulmonary hypertension (ph), syncope, due to unknown etiology, valve dysfunction, aortic, valve dysfunction, mitral, valve dysfunction, tricuspid, valve dysfunction, pulmonary, cor pulmonale, intrapulmonary shunting, renal dysfunction, not requiring dialysis, obesity, peripheral edema, sleep apnea, pneumonia, left upper lobe calcified granuloma, fibromyalgia, hysterectomy, back surgery, bacteremia (groshong catheter infection), dizziness, pre-syncope, jaw pain, headache, nausea, and chest pain.The event date was (b)(6) 2021.Additional information received from a rep indicated there was no resolution for this particular incident and no action was taken.In regards to the cause, it was noted it was unknown and was being investigated.No further complications were reported/anticipated.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) reported on (b)(6) 2021 the expected residual volume was 7.7ml and the actual residual volume was 17.0ml indicating a device malfunction.It was noted the pump accuracy was 71% and the flow rate accuracy was outside the expected range.No symptoms were reported (no impact to the patient) and no action was taken (no medical intervention required to prevent permanent injury or impairment).No assessment for product/therapy/procedure relatedness was performed.No further complications were reported/anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study and a company representative (rep) reported there was a device malfunction where on (b)(6) 2021.The expected residual volume was 11.6ml and the actual residual volume was 20 ml.The pump accuracy was 70% and flow rate accuracy was outside the expected area.The patient reported symptoms that started on (b)(6) 2021.No medical intervention was required.The cause of the volume discrepancies and resolution of the event were unknown and were being investigated.No further complications were reported/anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study and a manufacturer representative (rep) reported the patient had worsening dyspnea.It was noted beginning on 2021-(b)(6) the patient's flow rate accuracy began falling outside the acceptable range.Initially, the patient denied any increased symptoms.On 2021-(b)(6) during a routine clinic visit, the patient said that they had increasing shortness of breath and fatigue since around 2021-(b)(6).Additional medical intervention required to prevent permanent injury or impairment included pump interrogation, which was abnormal and showed the flow rate was outside the acceptable range (70%-72% per accuracy ratio calculation).An echocardiogram was normal for the patient.Other diagnostic tests/procedures (right heart catheterization) was normal for the patient.It was noted that the hcp ordered a dose increase of 4 ng/kg/min every 2 to 3 weeks until the patient's estimated delivery dose reached 60 ng/kg/min on 2021-(b)(6).The outcome was unresolved with further actions or treatment planned.The event was not related to the procedure, catheter, programmer, remodulin injection, refill process, catheter patency test, implant tools, or the catheter access port kit.The event was related to the pump.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the device manufacturer representative via healthcare provider and clinical study indicated that the issue was resolved.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 11708115
• MDR Text Key: 247221287
• Report Number: 3004209178-2021-06503
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Race: White