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

Model Number 8637-40

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

Patient Problems Apnea (1720); Coagulation Disorder (1779); Fever (1858); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Shock, Postoperative (2266); Complaint, Ill-Defined (2331); Irritability (2421); Vascular System (Circulation), Impaired (2572); No Known Impact Or Consequence To Patient (2692); Test Result (2695); No Code Available (3191)

Event Date 01/28/2020

Event Type  Injury  

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 regarding a patient receiving gablofen (unknown dose and concentration) via an implantable pump.It was reported the baclofen pump was placed on (b)(6) 2020.Examination on (b)(6) 2020 revealed altered vital signs.The patient developed tachycardia and agitation.On (b)(6) 2020 the patient developed 7 second apneic spells and a fever of 39 degrees celsius.It was noted the agitation continued despite treatment with increased pump rate, oral baclofen, tranxene and valium.On (b)(6) 2020 the patient developed hypotension, hemodynamic instability, rhabdomyolysis and acute kidney injury and coagulopathy due to liver failure.A catheter access port (cap) contrast study revealed radiographically baclofen pump system on (b)(6) 2020.Laboratory testing on (b)(6) 2020 revealed hemoglobin was 16.7, co2 was 26, bun (blood urea nitrogen) was 16, and creatinine was 1.07.Laboratory testing on (b)(6) 2020 revealed alt (alanine aminotransferase) was 4215, ast (aspartate aminotransferase) was 3076, ggt (gamma-glutamyl transferase) was 156, lactic acid was 2.8, and ck (creatine kinase) was 20, 385.The outcome of the event (including all symptoms) resolved without sequelae on (b)(6)2020.The clinical diagnosis was post-operative shock.The exact cause of the symptoms were not given.The patient's weight was (b)(6) kg.The event resulted in a life threatening illness or injury, required inpatient or prolonged hospitalization/prolongation of existing hospitalization, and resulted in a medical or surgical intervention to prevent l ife-threatening illness or injury or permanent impairment to a body structure or body function.The etiology of the event indicated the relationship of the event to the device or therapy was unlikely related and indicated the relationship of the event to the implant procedure was related.It was noted the full event (including symptoms) was thought to be related to surgery/anesthesia.The event date was (b)(6) 2020.No further complications were reported.

Manufacturer Narrative

H6: see additional patient code that was missing on previous report.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.

Manufacturer Narrative

H.6.Please note: the patient, device, method, result, and conclusion codes have been updated to reflect the new information.Only the codes list in this section apply to this event.All previously reported codes no longer apply to this event.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 reported on (b)(6) 2020 the patient was getting ventilator support.The patient was administered norepinephrine and epinephrine on (b)(6) 2020.The clinical diagnosis was updated to post-operative shock related to pneumonia.No further complications were reported.

• 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
• MDR Report Key: 10138353
• MDR Text Key: 196834271
• Report Number: 3004209178-2020-10056
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 36