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

Model Number 8637-40

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Dehydration (1807); Diarrhea (1811); Pain (1994); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2020

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 provider (hcp) via a manufacturing representative (rep) regarding a patient receiving 10 mg/ml of bupivacaine at 2.747 mg/day and 20 mg/ml of dilaudid at 5.495 mg/day via an implantable pump.It was reported the patient's pump recently reached the eri (elective replacement indicator) and showed the "replace pump by" date of (b)(6) 2020.It was reported the hcp silenced the non-critical alarm.On (b)(6) 2020 the pump started alarming again with a critical alarm and the patient was reporting pain, which they had not done before.It was reviewed to interrogate the pump.The hcp stated they would try to see the patient on (b)(6) 2020.Additional information was received from a consumer on (b)(6) 2020 reported on (b)(6) 2020 the patient¿s pump hit end of service.On (b)(6) 2020 the patient was brought to the emergency room (er) due to not being able to walk because of dehydration due to ¿crohn¿s like symptoms¿ of vomiting, withdrawal, diarrhea.It was noted 5-6 hours later she was discharged and now was home.It was further reported that a number of factors contributed to her not getting the pump replaced on time.The patient¿s mother reported the doctor said that the pump shortage affected the ability of the pump to be replaced this summer as expected and also that due to covid she could not have the pump replaced by a different doctor since they required 2 week quarantine prior to the replacement and the patient needed to have caregivers in home.

Manufacturer Narrative

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

Event Description

Additional information was received and it was reported that ¿the patient¿s health has been declining¿ and they were trying to get the pump replaced.Per the reporter, the referral healthcare provider would only switch out the device and would not fill pump/provide pain medication for the drive home and the reporter was uncomfortable with the arrangement.The reporter was inquiring if there was a way to check to see if the managing healthcare provider received pumps so he could perform the replacement.The reporter was redirected to the healthcare provider.

Manufacturer Narrative

H6: fdd codes a2303 and a1407 removed to correctly reflect 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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10832256
• MDR Text Key: 221296006
• Report Number: 3004209178-2020-19900
• 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,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR