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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Vomiting (2144); Sweating (2444); Alteration In Body Temperature (2682)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, information was received from a patient and healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving sufentanil (1,000 mcg/ml, 160 mcg/day) via an implantable pump for non-malignant pain.It was reported the patient had reached out to the hcp and reported that they thought their pump was going through motor stalls.The rep stated the hcp then reached out to them so the rep had met up with the patient to check the pump logs.No anomalies were found in the pump logs.The rep reported the patient, at one point, was watching tv and had their myptm handset with them and saw a warning saying they had a motor stall.The rep reported that the patient heard a single tone alarm and got really hot and sweaty and threw up that same day.The rep confirmed with the patient that they have not heard any critical alarms from their pump.The patient also kept track of the sound of their pump with a stethoscope and made note of the ticking sound the pump makes and the grinding sound it makes when giving a bolus over the 1 minute duration.The rep reported the patient sometimes only hears the grinding noise over a 20-45 second period when he thought it should be over the 1 minute duration, therefore, thought the pump might not be doing what it was supposed to.

• 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: 9998408
• MDR Text Key: 190492465
• Report Number: 3004209178-2020-07696
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Date Device Manufactured: 07/16/2019
• 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 Age: 51 YR