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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problem Pain (1994)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 8780 lot# serial# (b)(4), implanted: (b)(6) 2020, product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving an unknown drug of an unknown concentration at an unknown dose rate via an implantable pump.It was reported that the patient came for a pump refill, and a nurse reported less volume in the pump's reservoir.Overinfusion was indicated.There was approximately 1 ml in the reservoir and per the programmer the expected reservoir volume should have been 6.3 mls.The patient was not exhibiting signs of overdose or decreased pain.The patient was exhibiting increased pain.The pain being treated was of malignant origin.The pump was refilled every 3 weeks.The pump logs were read, and no abnormalities were found.There were no known environmental/external/patient factors that may have led or contributed to the issue.The issue was not resolved as of 2021-sep-23.No surgical intervention was planned.The patient was to be monitored and reassessed at the next refill for volume discrepancy.A refill was to occur in the next 2 to 3 weeks.The patient's weight and medical history were unknown or would not be made available.

Event Description

Additional information was received from a healthcare provider via a company representative.At the following planned refill, the volume was close to the expected volume with the range.No further diagnostic tests or troubleshooting was performed.The cause of the volume discrepancy / over-infusion and increased pain was not determined.No actions were planned / taken as the patient had stabilized.On (b)(6) 2021 the physician maintained the dose at 1.801.2 mcg of morphine per day.The company representative had spoken to the management team, and they had not heard from the patient, so they believed all was going well for the patient.They were to perform another pump refill before (b)(6) 2022.The pump was currently implanted / in use and would not be returned to the manufacturer.

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.

• 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: 12532723
• MDR Text Key: 273332974
• Report Number: 3004209178-2021-14426
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2021
• 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: 12/08/2021
• Date Device Manufactured: 03/26/2020
• 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 Sex: Female