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

Model Number 8637-40

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

Patient Problems Dyspnea (1816); Pain (1994)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id : 8709, lot/serial#: (b)(4), implanted: (b)(6) 2000, explanted: (b)(6) 2020, product type: catheter, ubd: unk, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) via the manufacturing representative (rep) regarding a patient receiving 20 mg/ml of morphine at 5.675 mg/day via an implantable pump.It was reported the patient was experiencing increased pain and difficulty breathing following a normal pump replacement on (b)(6) 2020.The patient did not feel the pump was delivering the daily dose.The patient was not experiencing any issues with their therapy prior to the replacement.The managing physician ordered a 10% decrease in daily dose to be programmed at replacement.The patient saw their managing doctor after replacement and the dose was increased back to the original dose prior to replacement.The patient went to the emergency room (er) on (b)(6) 2020 experiencing pain and difficulty breathing.The patient was discharged and returned to the er again on (b)(6) 2020, and was discharged.There were no environmental/external/patient factors that may have led or contributed to the issue.A catheter dye study was ordered for (b)(6) 2020.If unsuccessful, surgery would be scheduled for (b)(6) 2020 to replace the catheter.Additional information was received from the manufacturing representative (rep).The rep stated the patient's pain and difficulty breathing was due to a problem with the device or therapy.It was clarified the patient had not been hospitalized when they went to the er.The patient was sent home each time.Per the pump logs, the pump was running and delivering drug.A dye study was ordered on (b)(6) 2020 to confirm if the patient was actually receiving the drug.The doctor was unable to aspirate.The dye study was unsuccessful.It was concluded the there was a catheter issue based on the dye study findings.The catheter was not patent.The patient was brought in for surgery on (b)(6) 2020 and the catheter was replaced with a new 8780 catheter.The patient confirmed on (b)(6) 2020 that she was feeling better and longer experiencing any of the previous issues or symptoms.The information had been confirmed with the physician/account.

Event Description

Additional information was received from the rep who reported that the customer discarded the catheter.

Manufacturer Narrative

Continuation of d10: product id: 8709, serial# (b)(6), implanted: (b)(6) 2000, explanted: (b)(6) 2020, 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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10832261
• MDR Text Key: 216833871
• Report Number: 3004209178-2020-19901
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR