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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Overdose (1988); Oversedation (1990); Sedation (2368); Cognitive Changes (2551)

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 healthcare professional (hcp) and a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device.The drugs being delivered were 12 mg/ml fentanyl at 1.799 mg/day (also reported as 2.9 mcg/day), 20 mg/ml bupivacaine at 2.998 mg/day (also reported as 5.8 mg/day), 1,000 mcg/ml clonidine at 149.9 mcg/day (also reported as 261 mcg/day), and 20 mg/ml morphine (unknown) at 3 mg/day (also reported as 5.8 mg/day).The reason for use was spinal pain.It was reported that the patient was somnolent on (b)(6) 2018 and "kept getting narcan." the hcp also noted that the patient was intubated and sedated all night and they cut the patient's doses in half.Troubleshooting/results performed during the call consisted of the caller inquiring if the patient could access the pump or adjust their dosing.Information was reviewed, including basic pump function and the use of a ptm if the pump is programmed for use with one.The patient was obtunded and had over-sedation characteristics in addition to symptoms previously reported.The hcp also reported that the patient has "other things going on." the patient is currently in the cardiac icu (intensive care unit) after cardiac surgery on (b)(6) 2018, unrelated to the pump.However, her icu doctor requested a 50% reduction of pump rate to manage her pain ¿the way they normally do it.¿ environmental/external/patient factors that may have led or contributed to the issue included the patient was admitted after cardiac surgery and no details were reported.Interventions/actions that were taken to resolve the issue included a rate reduction of 50%.The issue was resolved at the time of this report, and the patient status was listed as ¿alive - no injury.¿on (b)(6) 2018 the doctor requested additional 25% reduction of infusion rate.The patient¿s daughter stated she would prefer the pump be removed.The hcp has no further information for the manufacturer.There were no further complications reported/anticipated.

Manufacturer Narrative

The pump was returned and analysis found no significant anomalies.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 the rep on 2019-jun-10.The product was returned to the manufacturer for analysis.There were no further complications 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
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7827888
• MDR Text Key: 118612321
• Report Number: 3004209178-2018-19449
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR