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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Information was received from a consumer regarding a patient receiving intrathecal bupivacaine 5 mg/ml at 1.3017 mg/day and morphine 10 mg/ml at 2.603 mg/day via an implantable pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient¿s pump was alarming.A pump study was done, and it showed a malfunction.They suggested replacing the pump.The pump was being titrated so it could be switched out.The patient¿s dose had been reduced every 2 weeks.The patient was ¿told that the pump was reduced 5% without being told.¿ it was noted that the healthcare provider (hcp) was no longer going to see the patient, and the patient was told that she was non-compliant.The patient did not currently have a hcp at this time.The event date was noted to be (b)(6) 2015.It was also noted that the patient said she was ¿late to an appointment.¿ there were no further complications reported.

Event Description

Additional information was received from a healthcare provider (hcp).It was reported that the patient¿s new managing hcp had additional questions about the patient.The hcp asked if there was a way he could obtain medical records for this patient since he was seeing that there was some history about the pump malfunctioning.The hcp would be seeing the patient in the next week or two (from (b)(6) 2017).Before then, he would contact the patient¿s previous managing hcp as well as reach out to manufacturing representatives to see if they had any additional information about this patient.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on (b)(6) 2017 from the patient¿s friend/family member who reported that the patient¿s pump had been malfunctioning since (b)(6) 2015.The patient had gone through a series of lowering the dosage down before shutting it off.The last refill was (b)(6) 2017, but they didn¿t empty it.They left the medication in there.The pump was shut off on (b)(6) 2017.The patient started going with withdrawal that day.Per the reporter, the patient for sure heard the alarm at 1 am today ((b)(6) 2017) but stated that it could have been earlier as the patient was going through withdrawal.Additional information was received on 01-sep-2017 from the patient who reported that the pa (physician¿s assistant) programmed the pump to minimum.The patient was going in on tuesday and wanted to make sure she understood that the pump could be turned off but that they would have to call for a code.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a patient.It was reported that patient's pump started alarming on (b)(6) 2017.The healthcare professional (hcp) didn't shut it down right.The hcp didn't call into the manufacturer to get the code to completely shut it down.The patient had been trying to find a hcp that would take the pump out.The pump started alarming on saturday night every 60 seconds for a total of 17 seconds which was a total of 26 beeps.Patient thought the battery would have died a while ago.With the beeping she was getting no sleep, she couldn't leave the house.She could hear the beeps through a t-shirt and a jacket.Patient was getting the dual tone alarm.Patient said her stomach was kind of sore.Patient said probably the last eight months or more.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 via a company representative.It was noted that the pump alarmed and had reached end of service (eos) as expected based on implant date.Steps to turn the pump alarm off by confirming terminal event message on the programmer was reviewed.It was noted that the company representative clicked ¿yes¿ which should disable the pump alarms.

Manufacturer Narrative

Device code (b)(4) is no longer applicable for 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.

Event Description

Additional information was received on (b)(6) 2020 from the patient who reported that her pump was taken out the same day her implantable neurostimulator was implanted.She stated that it had started malfunctioning in may 2015.It was shutting off just randomly leaving her with withdrawals for a couple of days.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: 6523210
• MDR Text Key: 73780830
• Report Number: 3004209178-2017-09119
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR