MAUDE Adverse Event Report: MEDTRONIC, INC. SYNCHOMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Failure to Shut Off (2939)

Patient Problems Fall (1848); Cognitive Changes (2551)

Event Date 06/14/2022

Event Type  Injury  

Event Description

Patient was implanted with this device and had a fall and had altered mental status due to the continuous infusion of hydromorphone and clonidine.The device was unable to be turned off to stop the infusion to reverse the hydromorphone in the patient's system.Due to this, the manufacturer needed to be called to send a technician to lower the dosing as to not precipitate withdrawal.Fda safety report id # (b)(4).

• Brand Name: SYNCHOMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; minneapolis MN 55432 5640
• MDR Report Key: 14756197
• MDR Text Key: 294510353
• Report Number: MW5110392
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLONIDINE; HYDROMOPRHONE
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White