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

Model Number 8637-40

Device Problem Ambient Temperature Problem (2878)

Patient Problems Abdominal Pain (1685); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving 2500 mcg/ml of fentanyl at 679.1 mcg/day and 250 mcg/ml of baclofent at 67.91 mcg/day via an implantable for non-malignant pain.It was reported the patient had been having episodes where he felt he was in withdrawal.The issue began about a week ago, relative to (b)(6) 2019.The patient recently had been working out and doing physical therapy.The patient also had a recent hip surgery and had been icing his right hip, right over the pump as well.The patient had been laying on an ice pack and the patient reported starting about an hour after doing the icing he starts having symptoms of: sweating, stomach hurting, "can't stop moving my body," and feeling the need to use the restroom frequently, but then not being able to do so.The patient stated this happened for a period of about 11 hours.The patient stated then it would resolve and they would feel okay.The patient's pump was interrogated and no issues were found.No alarms have been heard.Temperature considerations were reviewed with the patient.The patient stated they planned to discontinue the use of the icing and see if the problem no longer occurs.Additional information was received from the manufacturing representative (rep) on 2019-oct-23.The pump logs did not have any anomalies.The rep stated the patient vaguely explained to them that sometime in the past they had expected to get back 2 ml however the healthcare provider pulled back maybe around 10 ml from the pump.The rep stated they will be looking at the catheter next and will follow-up with the healthcare provider.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 company representative.It was unknown as to when the volume discrepancy occurred.It was not determined if the ice pack had affected infusion delivery.It was unknown if the patient¿s symptoms had resolved; the last known episode occurred on (b)(6)2019.The pump was interrogated, and the logs were read on (b)(6)2019.The cause of the patient¿s symptoms was not determined.The cause of the volume discrepancy was not determined.The patient has a refill scheduled for (b)(6)2019 and a volume comparison was to be performed then with possible dye study.The patient may make an appointment to see their healthcare provider in advance of this appointment.The volume discrepancy issue had not resolved.The patient weight was unknown, and the company representative would provide and update when known.The information was noted as having been confirmed with the physician/account.

• 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: 9235273
• MDR Text Key: 171586308
• Report Number: 3004209178-2019-20370
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Date Device Manufactured: 02/04/2014
• 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