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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problems Abdominal Pain (1685); Nausea (1970); Pain (1994); Vomiting (2144); Dizziness (2194); Therapeutic Response, Decreased (2271)

Event Date 05/20/2019

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 healthcare provider (hcp) regarding a patient receiving intrathecal clonidine 62.5 mcg/ml at 32.273 mcg/day and unknown morphine 21.8 mg/ml at 11.257 mg/day via an implanted pump for non-malignant pain.It was reported the hcp was interrogating the pump to confirm it was functioning.The hcp was concerned that the pump was not working and the patient was going through withdrawal.No issues were found at pump interrogation, but the hcp needed assistance with printing.The patient was experiencing severe abdominal pain and the change in therapy/symptoms was sudden.The hcp was assisted with creating and printing a print report.The event date was asked and unknown.Additional information was received from a healthcare provider (hcp) on (b)(6) 2019 indicated there have been numerous motor stall and recoveries beginning (b)(6) 2019.It was noted both the hcp and the patient heard the pump alarming.The patient had went to the emergency department (ed) and they stated everything was ok with the pump but it was reported they must not have looked at the logs because they would have seen the motor stall issue at that time.The hcp was inquiring about next steps and the hcp would confer with the patient and pump follow-up doctor.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) indicated the withdrawal and severe abdominal pain were first noticed on (b)(6)2019.It was noted the cause of the motor stalls was not determined and the patient denied having contact with any magnetic source.The patient¿s pump was placed in minimum rate mode.He was given oral medications to counteract withdrawal and was given an urgent referral to the surgeon for a pump replacement.The patient¿s weight at the time of the event was unknown.Regarding the current status, the device continued on minimum rate mode.Replacement was tentatively scheduled for (b)(6)2019.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) on 2019-may-24 indicated the patient first came into the emergency room (er) on (b)(6) 2019.The device was interrogated and there was no device issue.It was noted an esophagogastroduodenoscopy (egd) was performed which showed that the patient had severe gastritis which was causing abdominal pain, nausea, and vomiting.It was reported the patient was not in withdrawal, and the abdominal pain was caused by severe gastritis.The patient was started on a proton pump inhibitor.The event had been resolved and the patent's weight at the time of the event was unknown.She stated the device remained implanted and there was no problem with the device.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received on 21-jun-2019 from the patient via a company representative who reported that the patient experienced having fluctuations between feeling great and then having withdrawal symptoms when the pump was intermittently stalling.The patient was unaware of any environmental,external, or patient factors that may have led or contributed to the issue.The patient status was reported as ¿alive ¿ with injury¿ with the detail of the injury provided as ¿patient stated admitted to emergency room (er) due to withdrawal symptoms of generalized pain, nausea, vomiting, dizziness¿.It was noted that the patient thought the er admission was in the early morning on (b)(6) 2019.The pump was replaced on (b)(6) 2019.The issue was resolved.No further complications were reported/anticipated.

Event Description

The device was returned to the manufacturer for analysis.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent once analysis is complete.The evaluation codes have been updated 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.

Manufacturer Narrative

H3: evaluation of implantable pump serial number (b)(6) revealed the following.Destructive analysis identified wearing on the upper shaft of gear number two.In addition, during dispense accuracy testing, the pump exceeded the dispense accuracy specification by dispensing more fluid than the programmed rate during one of four tests.H6: the evaluation codes have been updated for this event.Code-conclusion 24 applies to the shaft wear and code-conclusion 4315 applies to the dispense testing results.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: 8666924
• MDR Text Key: 146939743
• Report Number: 3004209178-2019-10829
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Date Manufacturer Received: 08/14/2019
• 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: 57 YR