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 Syncope (1610); Low Blood Pressure/ Hypotension (1914); Pain (1994); Complaint, Ill-Defined (2331); Loss of consciousness (2418)

Event Date 02/16/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional regarding a patient receiving clonidine (550 mcg/ml at 74.83 mcg/day), bupivacaine (40 mg/ml at 5.443 mg/day), and morphine (25 mg/ml at 3.402 mg/day) via an implanted pump.The indication for pump use was spinal pain.On (b)(6) 2017 it was reported that the patient presented with syncopal episodes and periods of hypotension which had come on suddenly on (b)(6) 2017.There was no alarm sounding on the pump.The reporter was calling because they wanted someone to come to the hospital to check out the patient¿s pump too make sure the patient wasn¿t getting too much clonidine due to the episodes and because he had ¿passed out¿.The reporter did not believe there was an issue with the pump, but the attending wanted it checked.They would not be accessing the reservoir.The pump was lasted refilled in (b)(6) 2016 and they were not aware of any adjustments since that time.The patient¿s managing physician did not have privileges at the hospital.The situation was being addressed by the reporter¿s facility.

Manufacturer Narrative

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

Information was received from a healthcare provider regarding a patient receiving an unknown drug via an implantable pump.The indication for use was spinal pain.The healthcare provider requested compatibility guidelines for an mri.The mri was not due to a problem with the device or therapy.The mri was being performed to rule out a mass and because the patient was having back pain.

Manufacturer Narrative

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
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6360390
• MDR Text Key: 68381614
• Report Number: 3004209178-2017-04613
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: Not provided; 02/27/2017
• Supplement Dates FDA Received: 02/28/2017; 10/02/2017
• Date Device Manufactured: 07/10/2013
• 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): Hospitalization
• Patient Age: 62 YR