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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Chills (2191); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444); Shaking/Tremors (2515)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving clonidine, bupivacaine, and morphine at unknown doses and concentrations via intrathecal drug delivery pump.The indication for use was noted as non-malignant pain and failed back surgery syndrome.It was reported that the pump was alarming every 2 minutes (but later stated it was beeping every 10 minutes) since (b)(6) 2018.The patient was supposed to go in to have her pump replaced on (b)(6) 2018, but the healthcare provider (hcp) called and cancelled on (b)(6) 2018.The patient was experiencing sweats, diarrhea, the shakes, and feeling cold.She had to go to the emergency room (er) twice and was still experiencing it as of (b)(6) 2018.She went back to the doctor on (b)(6) 2018.This issue started right after the nurse came out to her house of (b)(6) 2018.She was feeling sick when the nurse got there, but the nurse thought the patient was maybe coming down with a bug since the pump was checking out fine.Her pump started to alarm after the nurse left.There were no further complications reported at this time.Additional information was received from the consumer on (b)(6) 2018.The patient reported they were getting really sick around their stomach where their pump was located, and the alarm was also affecting their ears because they were hearing the pump alarm every 10 minutes.The patient confirmed they were still experiencing some withdrawal symptoms.The patient inquired about the risks of the pump alarming.The patient had an appointment with their managing doctor on friday (b)(6) 2018 and said they did not know anything about it.The patient stated they did not check or interrogate her pump, but they told her the pump needed to be replaced because it was defective.The patient stated the reason it was defective was because the battery was supposed to last 7 more months.The patient stated their doctor referred them to a back surgeon to replace the pump.It was indicated the patient's medication had been getting decreased and the patient stated their healthcare provider who refills their pump wanted to make sure the patient does not have too high of a dose refilled by the surgeon.The patient stated the night before, and the night before that ((b)(6) 2018), the patient started to have new symptoms and their symptoms were getting worse.The patient planned to see their new surgeon (b)(6) 2018.It was indicated this was a consult appointment.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.It was reported that no environmental, external, or patient factors were reported to have caused this issue.The device was programmed to deliver morphine (25mg/ml at 11.5mg/day), clonidine (588mcg/ml at 270mcg/day), and bupivacaine (15mg/ml at 6.9mg/day).The pump and catheter were replaced on (b)(6) 2018.The old catheter was tied off per guidelines.Per the logs ran on 2018-oct-19, it looked like intermittent motor stalls and recoveries since 2018-aug-06.The issue was resolved and the patient was "alive - no injury." there were no further complications reported at this time.

Manufacturer Narrative

(b)(4) no longer applies.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.Interrogation of the pump on (b)(6) 2018 showed it was programmed to deliver morphine (12.5mg/ml at 4.975mg/day), clondine (294mcg/ml at 117mcg/day), and bupivicaine (7.5mg/ml at 2.9848mg/day).The patient had a motor stall at 4:35 on (b)(6) 2018 and recovery at 5:00.Another motor stall occurred at 10:46 on (b)(6) 2018, recovery at 11:01.Another motor stall occurred at 10:19 on (b)(6) 2018, recovery at 10:28.Another motor stall occurred at 13:22 on (b)(6) 2018, tube set occurred at 13:22 on (b)(6) 2018, recovery occurred on (b)(6) 2018.There were no further complications reported at this time.

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 on 2019-jul-01.The caller mentions that she currently does not have a hcp to manage her pump and she needs a listing of hcp¿s.The caller is wondering whose name should be indicated on the id card as the managing doctor.They then repeated/mentioned that with her previous hcp, she went through withdrawals because the doctor was waiting for authorization for the medication "or something." there were no further complications reported/anticipated at the time of the report.

Manufacturer Narrative

Device code: c53269 no longer applies.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Manufacturer Narrative

Analysis of the implantable pump (b)(4) identified residue in the motor gear train and wearing of the shaft of the gear or the rotor.During dispense accuracy testing, the pump exceeded the dispense accuracy specification by dispensing more fluid than the programmed rate.(b)(4).Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 MN 00777 1200
• MDR Report Key: 7948577
• MDR Text Key: 123195536
• Report Number: 3007566237-2018-02980
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR