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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving an unknown medication via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2018 it was reported that the patient was in the office for a normal refill.Interrogation showed 2 ml should be in the reservoir; however, 16 ml was aspirated.The patient did not report any withdrawal symptoms.There were no known environmental, external, or patient factors that may have led or contributed to the issue.The physician programmed the pump to minimum rate and was planning to bring the patient back to the office at their next appointment on an unknown date.It was unknown if the issue was resolved at the time of the report.No surgical intervention had occurred, and it was unknown if surgical intervention was planned for the future at the time of the report.The patient status was reported as ¿alive ¿ no injury¿.It was noted that the hcp had no further information regarding the event.No further complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via the food and drug administration (fda) on (b)(6) 2018.It was reported that the pump was implanted on (b)(6) 2014, and was refilled every 90 days or so.Problems were reportedly indicated by the amount of morphine left in the pump when it was time for refill.It was adjusted numerous times, but pain in the back was unabated.Break-through pain meds were administered in the form of oxycodone (15mg), which were the pain meds the patient was trying to get off of and led to the pump implantation.As recent as last week (relative to (b)(6) 2018), the problem was again identified and a procedure was to be scheduled to infuse contrast dye into the pump and "leads" to determine whether there was a kink in the catheter or a leak from the pump.It was discovered that the pump was under recall, and the consumer had never been informed of any recall.The consumer reportedly felt that this was a severe issue which could be life threatening.Concomitant medications included zetia, neurontin, clopidogrel bisulfate, metoprolol tartrate, trazodone, ancept, benazepril, seroquel, namenda, and rapatha.It was indicated that the event was life threatening and required intervention.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the company representative went to the hospital to interrogate the pump prior to explant.The patient and their spouse expressed dissatisfaction with the pump.They stated it ¿never worked right¿.The spouse read on-line that the pump had been "recalled" and they blame a problem with the pump for not working.They also stated they felt the physician didn't work with the pump correctly.Apparently the patient didn't want to use the pump anymore, and the physician programmed the pump to minimum rate and the patient wasn¿t seeing that physician anymore.The pump was used to deliver dilaudid 20mg/ml at minimum rate.It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue or if any diagnostics or troubleshooting had been performed.The actions and interventions taken to resolve the issue was the patient decided to have the pump/catheter explanted.The issue was resolved at the time of the report and it was indicated that the physician would not have any further information regarding the event.The patient status was noted as alive, no injury and no further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type catheter.Other relevant device(s) are : product id: 8780, serial# (b)(4), ubd 2015-09-11 udi# (b)(4).Analysis of the pump revealed no anomaly.Analysis of the catheter revealed catheter body damage to transition tube.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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
• MDR Report Key: 7544107
• MDR Text Key: 109237150
• Report Number: 3004209178-2018-11862
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR