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); Pumping Stopped (1503); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Malaise (2359); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: neu_ptm_prog, serial#: unknown, product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and healthcare provider via manufacturer representative regarding a patient who was receiving clonidine (concentration: 100 mcg/ml, dose rate: 42.46 mcg/day) and dilaudid (concentration 10 mg/ml, dose rate: 4.246 mg/day) via an implantable pump for spinal pain.It was reported that the patient had their pump replaced this morning ((b)(6) 2021) and everything went well.The patient was home now and had stated that their pump was alarming.The company representative checked session long report from the procedure and noted that the pump had a pending alarm.The company representative was not with the patient.  at the time of the report it was reviewed that the pump needed to be interrogated to confirm the alarm.  the patient was described as very angry and wanted to know why the pump was alarming.  the pump was alarming every 20 minutes.  the ptm was checked and there were no alarms noted.The patient was hearing the alarm about every 3 to 5 minutes.  the patient was in pain.The personal therapy manager (ptm) was not connecting with the pump.  the ptm was however connected to the pump at the time of the call as the patient was reading the lockout time remaining during the conversation.  the patient described that the alarm they were hearing was a long tone such as a heart monitor when a patient is flatlining.  at the time of the report it was being considered that this was not a sound the pump has.  alarm intervals were reviewed.  the patient however insisted it was her pump.  it was further indicated that even though the ptm said its working, that it may not be.The patient stated she had a defective pump.  the patient refused to move to other locations of her home to see if she would hear the alarm.  the patient also noted that since they got home from the hospital and was hearing the pump alarming, she had been able to give herself 2 boluses.  the patient was not feeling well, was in pain, and could hardly breathe.  the company representative talked to the patient again later on (b)(6) 2021 and the patient was seeing the pump not found message on their personal therapy manager.  the patient's physician had advised the patient to go to the emergency room (er), but the patient said no because they were not going to help her.  they called the patient back again, and by this time the patient had indicated that they were connected and that their ptm was saying she had 3 plus hours remaining.  the patient had got locked out again without receiving a bolus.  while they were on the phone with the patient, a loud alarm went off.The alarm did not sound like the critical alarm.  the patient was agitated and convinced it was the pump regarding the alarm heard.The patient confirmed they had no other kind of medical equipment and the patient was in her bedroom.The patient wanted to contact their physician and the company representative had agreed.  on (b)(6) 2021 the company representative further reported the patient had called with withdrawal.  the company representative was to see the patient and was going to check the pump.  it was further noted that the physician might do a dose adjustment.

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.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 provided by the manufacturer representative (rep).It was reported the logs showed a motor stall occurred at 8:10 am and recovered at 9:45 pm on 2021-feb-20 while the pump was in shelf state.The pump was audibly alarming again on 2021-mar-01.The hcp was able to successfully update the pump and silence the active alarm.The pump logs confirmed that the alarm was silenced.

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 received reported that they did not know of any factors that may have caused the motor to stall prior to implant but it may have been a motor stall that occurred before they received the pump.The alarm that the patient heard following implant was due to the pending alarm.The cause of the patient¿s symptoms was not determined.The doctor could not confirm any withdrawal symptoms and the patient was ok the day they met with her.The cause for the ptm indicating pump not found was not determined, this happened when the patient was home.The cause for the unexpected lockouts was not determined.The actions and interventions taken to resolve the unexpected lockouts and difficulty communicating was they verified that any pending alarms were silenced and they checked the logs.The patient¿s symptoms and the difficulty with the ptm connecting to the pump and unexpected lockouts were resolved and all was ok at the this time.

• 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: 11407590
• MDR Text Key: 234723411
• Report Number: 3004209178-2021-03634
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 76