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

Model Number 8637-20

Device Problems Device Alarm System (1012); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Chills (2191); Sweating (2444); Diaphoresis (2452)

Event Date 08/19/2020

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

Event Description

Information was received from a patient who was receiving an unknown concentration of bupivacaine at 3.336 mg/day and unknown concentration of fentanyl at 200.1 mcg/day via an implantable pump for non-malignant pain.On (b)(6) 2020, it was reported that the patient felt that the pump was not working.The patient clarified that they had been in severe pain and were experiencing cold and hot sweats for 6 hours that day.According to the patient, the same symptoms had hit them last week for a couple of days.The patient met with their healthcare provider (hcp) on (b)(6) 2020 and the hcp increased the medication but did not check the pump.The patient confirmed that they had discussed their symptoms with the hcp.On 2020-sep-09, additional information was received from the patient via a manufacturer representative (rep).The patient reported an intermittent "beep" coming from the patient's pump, but it was inconsistent.This issue began (b)(6) 2020.There were no noted environmental, external, or patient factors that may have led or contributed to the issue.The rep interrogated the pump and read the logs.They did not reveal any active or past alarms.The rep also played the alarms for the patient and they stated these were not the alarms they were hearing.The issue was not resolved at the time of this report.Additional information was received from a company representative (rep) via the return paperwork on (b)(6) 2020 indicated the pump was replaced.It was noted there was no patient injury and the patient status after the device was removed was recovered without sequela.It was further reported the event was device related and the patient stated the pump worked intermittently and it was alarming; however, there were no alarms noted when the pump was interrogated.A dye study was performed with good results.

Event Description

Information was received from a healthcare provider (hcp) via the manufacturer's representative (rep) regarding a patient who had an implantable pump.On (b)(6) 2020, it was reported that the patient's pump was not providing therapeutic effect, so the patient requested to have the pump explanted.It was noted that, after the pump was explanted, the patient's pain "went through the roof".The patient recently received a new pump to help with the pain and needed help decoupling and recoupling the patient's personal therapy management programmer (ptm) to pair it with the new pump.

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.

Manufacturer Narrative

H3: analysis of the implantable infusion pump (s/n (b)(6) found no anomalies and the device passed all testing in the laboratory.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: 10795728
• MDR Text Key: 216672521
• Report Number: 3004209178-2020-19428
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR