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

Model Number 8637-20

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

Patient Problems Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Chills (2191); Anxiety (2328); Diaphoresis (2452); Dysuria (2684); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving fentanyl (2000 mcg at 900.32971 mcg/day), bupivacaine (5.1 mg at 2.29584 mg/day), and dilaudid (hydromorphone) (3.3 mg at 1.48554 mg/day) via an implantable pump for unknown indications for use.It was reported that the patient was feeling as if they were in withdrawal since june and weaning boluses.It was noted that they had a headache, increased sweating, dyspnea, high blood pressure and tachycardia.A change in boluses was programmed to 30mg with 10 options per day.Additional information received from the healthcare provider via a clinical study indicated that the patient continued to have withdrawal symptoms that included a runny nose/eyes and premenstrual symptoms.Additional information received from the healthcare provider (hcp) via clinical study (sdy) reported that the patient continued tp experience withdrawal symptoms (dysuria, cold sweats, jitters, muscle cramps, dysosmia) similar to last experience.The spinal catheter was replaced on (b)(6) 2022.They discontinued boluses and increased sc to 1200 mcg.

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8782, serial#: (b)(4), product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 22-oct-2022, 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.

Event Description

Additional information received from the healthcare provider via a clinical study indicated that the patient continued to experience withdrawal symptoms of muscle aches, diarrhea and fatigue.

Manufacturer Narrative

Continuation of d10: product id 8782.Serial# (b)(6).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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16092646
• MDR Text Key: 306590593
• Report Number: 3004209178-2023-00084
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2023
• Date Device Manufactured: 08/12/2009
• 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: Female
• Patient Weight: 92 KG