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

Model Number 8637-40

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

This device is a part of the group of 3 pumps.It is not the fourth pump.This device is included in the medical device correction, "model 8870 software application card used in the 8840 n¿vision¿ clinician programmer for synchromed implantable infusion system therapy", customer letter (september) 2013.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

Information was received from a health care provider (hcp) via a manufacturer representative regarding implantable drug infusion pumps.It was reported the representative had an account that he worked with that implanted pumps into dogs for amyotrophic lateral sclerosis (als).The representative reported the account was seeing the low reservoir and/or the empty reservoir when ¿they telemetry the pump¿.The representative stated the account did not hear any alarms from the pump when the pump presented itself with one of these messages.The representative stated everything else seemed correct such as the expected versus actual volume.The representative wanted to know if that would have anything to do with the new software card for the 8840 physician programmers.No symptoms/complications were reported.The representative stated he didn¿t not have more information about the event, so he would have a nurse call into tech support to review.The representative did not know how many pumps were affected by the issue.The drug used in the pumps was ¿riolesaol¿ (spelled phonetically) with unknown concentrations and doses.Additional information received on 2017-jul-28 from a nurse reported four pumps were used for the study.At the pump refill, it was noted that the pump should have had between 7-8 ml in the tank, and that was what they were removing from the pump.They would get the error message on the programmer for low or empty reservoir on all four pumps.It didn¿t happen at every refill.It happened that last two times.The pumps never went empty.The low reservoir alarm was 1 or 2 ml.The cause of the low/empty reservoir message on the programmer was not determined.They were only using one programmer.They had a work-around for the issue.They would go into the programmer and lie to it and say there is 20 ml.An alarm was not heard; the cause of there being no audible alarms was not determined.The pumps seem to be functioning fine.There were 3 pumps that had this issue.There was no issue with the fourth pump as they were not using the pump.They were getting the error on the programmer after the aau version software update.

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id 8840, serial # (b)(4), product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the hcp reported the last two refills occurred on (b)(6) 2017.

Manufacturer Narrative

Continuation of d11: product id 8637-40 serial# (b)(6) product type pump.Product id 8637-40 serial# (b)(6) product type pump.Product id 8870 serial# unknown product type software.Product id 8637-40 serial# (b)(6) product type pump.H6: due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.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: 6765257
• MDR Text Key: 83466572
• Report Number: 3004209178-2017-16210
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: PENDING
• Patient Sequence Number: 1