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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Vomiting (2144); Shaking/Tremors (2515); Insufficient Information (4580)

Event Date 11/08/2022

Event Type  Injury  

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient who was receiving dilaudid (hydromorp hone) (30 mg/ml at 3.39 mg/day) via an implantable pump for unknown indications for use.It was reported that since the patient's standard eri (early replacement indicator) pump replacement on (b)(6) 2022, the next day (b)(6) 2022 the patient noticed withdrawal symptoms and was feeling unwell.The patient reported shakes, vomiting, increased blood pressure, and increased pain.It was noted that at time of the pump replacement on (b)(6) 2022, the physician accidentally cut the catheter (which was already deemed patent and functioning properly via aspiration from the cap (catheter access port)) while trying to free the catheter up from tissue around it.The physician then used a proximal splice kit and reconnected the catheter pieces together. a pump check was ordered on (b)(6) 2022 by the physician.During the pump/catheter check, the physician was unable to aspirate the catheter at all.A revision catheter surgery was scheduled for (b)(6) 2022.In the mean time, the physician was going to supplement the patient with oral medication.The issue was not resolved at the time of report.The patient's weight and medical history were asked but unknown.The patient's status at the time of report was listed as "alive - no injury".

Manufacturer Narrative

Concomitant medical devices: product id: 8780, serial/lot#: (b)(4), implanted: (b)(6) 2016, product type catheter, product id: 8784, serial/lot#: (b)(4), implanted: (b)(6) 2022, product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 05-feb-2018, udi#: (b)(4); product id: 8784, serial/lot #: (b)(4), ubd: 30-sep-2023, udi#: (b)(4).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

Continuation of d10: product id 8780 lot# serial (b)(6) implanted: on (b)(6) 2016 : product type catheter product id 8784 lot# serial (b)(6) implanted: on (b)(6) 2022 explanted: on (b)(6)2022 product type catheter 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 was received from a healthcare provider (hcp) via a company representative (rep) reporting the catheter revision occurred as planned on (b)(6) 2022.After close inspection of all connection sites, it appeared the issue may have been at the sutureless connector piece.It looked as if tissue was inside the sutureless connector clogging it up.A new proximal catheter piece with a new sutureless connector was used.The hcp then accessed the catheter access port (cap) and the catheter was easily aspirated.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2016, product type catheter product id 8784, serial# (b)(6), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type catheter.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 company representative (rep) reporting that replacing the catheter piece resolved the issue.

Manufacturer Narrative

H3: analysis of catheter model 8780 with serial number (b)(6) found no significant anomaly ¿catheter body melted at or after explant ¿ did not affect infusion¿.Analysis of catheter model 8784 with serial number hg5qlla01 found ¿catheter body ¿ slice cut not related to explant damage¿ and ¿biological material in cup of sc (sutureless connector) connector¿.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.

• 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: 15840732
• MDR Text Key: 304101570
• Report Number: 3004209178-2022-15368
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634094
• UDI-Public: 00763000634094
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 12/30/2022; 03/03/2023
• Supplement Dates FDA Received: 12/27/2022; 01/04/2023; 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male