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

Model Number 8637-40

Device Problem Excessive Heating (4030)

Patient Problems Discomfort (2330); Alteration In Body Temperature (2682)

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Interrogation of the pump upon receipt indicated that the pump was delivering baclofen (1,000.0 mcg/ml at 103.1 mcg/day).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare professional (hcp) via a company representative regarding a patient receiving baclofen via an implanted pump.On (b)(6) 2020 the patient¿s mother reported that the patient¿s pump site was getting warm/hot to the touch.The pump was heating up and causing the patient discomfort.The event date was asked but noted to be unknown.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.It was noted that pump eos (end of service) was approaching in (b)(6) 2020.No diagnostics and/or troubleshooting had been performed.The physician wanted to replace the patient¿s pump; however, surgery had not yet been planned.The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.The patient status was reported as ¿alive ¿ no injury¿.Additional information was received on 02-sep-2020 which indicated that the pump was replaced.No further complications were reported/anticipated.

Manufacturer Narrative

H3: analysis of the pump revealed no anomaly.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10506578
• MDR Text Key: 206097011
• Report Number: 3004209178-2020-15559
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention