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

Model Number 8637-20

Device Problems Increase in Pressure (1491); Insufficient Information (3190)

Patient Problem Overdose (1988)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received on 2018-oct-24 from a patient who was receiving dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for spinal pain.It was reported that while the patient was in the hyperbaric chamber, he felt and heard a pop from the pump site when the technician increased the pressure.The pump was more than half full.The patient would follow up with his managing healthcare professional.No further complications were reported.Additional information was received on (b)(6) 2018 from the patient.It was reported that since this issue happened with the hyperbaric chambers, the patient felt the pump pop again when getting it refilled 'today.' he felt like the housing of the pump was flexing back and forth.He notified his healthcare professional (hcp) who said it was basically not possible.The hcp took pictures over fluoroscopy and did not see any issues.The hcp was able to fill 20ml in the pump successfully.The patient's concern was that the titanium casing cracked and now it would leak, or that it was flexing out now rather than concave and overdosing him.The patient was receiving dilaudid and bupivacaine at 20 mg/ml.The 24 hour dose was 3.754; 8 boluses of 0.05 mg; max daily dose 4.133 mg.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).The hcp reported the patient heard popping from their pump when doing a hyperbaric treatment.The hcp checked the pump after the hyperbaric treatment and the logs were normal and they hcp was able to fill the pump to capacity.The hcp reported that the popping only happened during the hyperbaric treatment.No further complications were anticipated/reported.

Manufacturer Narrative

Analysis of the implantable infusion pump (s/n (b)(4)) found no significant anomalies.If information is provided in the future, a supplemental report will be issued.

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.

Event Description

Additional information was received from the patient and a healthcare professional (hcp) via a company representative who reported that on (b)(6) 2019 the patient¿s pump was replaced because it had reached eos (end of service).There were no issues with the patient¿s therapy, but randomly he heard a popping noise coming from the pump.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be ¿patient reported being in pressurized area¿.The issue was noted to be resolved at the time of this 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¿.No further complications were reported/anticipated.

• 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: 8091595
• MDR Text Key: 127953736
• Report Number: 3004209178-2018-25892
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 12/04/2018; 12/09/2019; 02/19/2020
• Supplement Dates FDA Received: 12/05/2018; 12/10/2019; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR