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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Application Program Problem (2880)

Patient Problems Encephalopathy (1833); Pain (1994); Confusion/ Disorientation (2553)

Event Date 04/02/2018

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 healthcare provider via a company representative regarding a patient receiving dilaudid 15mg/ml at 0.720mg/day and clonidine 3.0mg/ml at 0.1441mg/day via an implantable pump.The patient¿s medical history included chronic pain.The indications for use were non-malignant pain and failed back surgery syndrome.On(b)(6) 2018, it was reported that the patient had signs of confusion and was brought to the hospital for evaluation.The physician was called yesterday, (b)(6) 2018 to interrogate the pump and noted a motor stall.The physician called the company representative the day of the report at approximately 11:30 am and asked if she could go check the pump.The company representative interrogated the pump and also noted a motor stall, however it does not show up in the event logs.The reason was unknown.There were no known environmental, external or patient factors that may have led or contributed to the issue.The diagnostics and troubleshooting included the pump was interrogated.The actions and interventions taken to resolve the issue was the physician was notified for oral/iv (intravenous) management.The issue was not resolved at the time of the event.Surgical intervention did not occur and it was unknown if it was planned.The patient status was noted as alive, no injury and 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 on (b)(6) 2018 and it was reported that the company representative made the nurse who was caring for the patient aware that the pump had stalled.The company representative called the physician¿s office and spoke with the staff.A message was also sent to the managing physician.The patient was getting ready to be moved to a different facility and the company representative sent an email to the company representative in that area to make him aware of the situation.The next day the company representative spoke with the managing physician and he had not heard any updates on the patient since he was not the admitting physician.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 from the healthcare provider who reported that the actions and interventions taken to resolve the motor stall was they contacted the company representative and started the patient on oral meds.The current status of the pump was reported as still in stall.They plan to replace the pump.No further complications were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Interrogation of the pump determined it was also used to infuse bupivacaine 3.0 mg/ml at 0.1441 mg/day.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.It was reported that a motor stall was seen at initial interrogation.The patient recently had an mri.The mri that the patient had was around the beginning of (b)(6)2018.The patient was then diagnosed with pres (posterior reversible encephalopathy syndrome).When the pump was initially interrogated, the alert message popped up stating that there was an active motor stall.However, in the logs, there was nothing that states that the pump motor had stalled, and the logs went back to (b)(6)2018.The patient had not heard any active alarms.The device manufacturer representative was not seeing the silence alarm button on the alarms tab.It was reviewed that this meant that the alarms must have been silenced, which was why they did not hear an active alarm.The last refill was (b)(6)2018.The healthcare provider (hcp) did not know if there were any volume discrepancies.The device manufacturer representative reported that the hcp was not wanting to check for a volume discrepancy, and just wanted to replace the pump and send it back to the manufacturer for analysis.It was reviewed that since the logs could only hold 30 events, the motor stall message was booted out of the logs, which was why they did not see the motor stall message.It was not very clear whether the patient had withdrawal symptoms or not.The patient did have more pain around the beginning of (b)(6)2018.No further complications were reported.

Manufacturer Narrative

Analysis of the pump revealed pump motor high resistance or open coil.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7398728
• MDR Text Key: 104419530
• Report Number: 3004209178-2018-06512
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR