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); Material Integrity Problem (2978)

Patient Problems Fatigue (1849); Decreased Respiratory Rate (2485); Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780, serial#: (b)(4), explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 13-nov-2016, udi#: (b)(4).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) regarding a patient who was receiving dilaudid (hydromorphone) (85.9 mg/ ml at 4 mg/day) via an implantable pump for unknown indications for use.It was reported that one hour after pump was refilled on (b)(6) 2022, patient started exhibiting somnolence and shallow respirations.  the patient was admitted into an emergency room (er).Narcan was given and they were released.Four days later on (b)(6) 2022, patient started exhibiting signs of somnolence and became obtunded.Patient was life flighted and admitted through the er into the hospital the evening on (b)(6) 2022.They started on a narcan drip and the pump infusion rate of hydromorphone was decreased from 12 mg/day to 4 mg/day.The concentration of the hydromorphone at this time was documented as 85.9 mg/ml.Patient's symptoms of overdose resolved by the following day.The event of overdose symptoms occurred after most recent pump refill as described above. on (b)(6) 2022, at time of pump replacement, the actual residual volume of drug withdrawn from the explanted pump was 18.9 ml as compared to the estimated residual volume of 19.1 ml.The withdrawn medication was discarded. the elective replacement indicator (eri) was activated and scheduled to replace the pump on (b)(6) 2022.This planned pump replacement was done on (b)(6) 2022.The pump was replaced without incident and the catheter was easy to withdraw cerebra spinal fluid.New concentration of hydromorphone 15 mg/ml was placed in reservoir.Patient restarted at infusion rate of 4 mg per day.  concomitant back fusion surgery was done following pump replacement and ascenda catheter was deliberately cut by orthopedic surgeon.The catheter segments were spliced together with connector from 8785.The issue was resolved at time of this report.Patient status was alive no injury.

Manufacturer Narrative

H3:analysis determined the pump reached its elective replacement indicator (eri) based on time progression, as expected.Continuation of d10: product id 8780, serial# (b)(6), 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.

• 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: 13290883
• MDR Text Key: 284347702
• Report Number: 3004209178-2022-00836
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG