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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503); Volume Accuracy Problem (1675); Intermittent Infusion (2341); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2017

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 health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for non-malignant pain.The pump contained an unknown brand of morphine [10 mg/ml] at a dose of 1.2 mg/day.It was reported the patient was in the clinic on the day of report for a routine refill.Upon interrogation of the pump, motor stall and tube set messages were received.The logs confirmed a motor stall on (b)(6) 2017 which was the date the patient had an mri while hospitalized for a broken hip due to a fall.The patient had a hip replacement.The pump was not interrogated after the mri.The reservoir was accessed, and the hcp aspirated the pump within 1 ml of the expected reservoir volume (29 ml).The pump reservoir was refilled with 40 ml and was updated.The hcp would periodically read the pump to see a motor stall recovery message.The patient had not heard any audible alarms and remained asymptomatic with no changes to her therapy.An additional motor stall and recovery on (b)(6) 2017 was mentioned while viewing the logs, and it was related to an mri.No patient complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative indicated that during a catheter revision surgery the pump logs were read and show multiple motor stall and recoveries.It was reported that a motor stall with recovery occurred on (b)(6) 2017, motor stall on (b)(6) 2017 with recovery on (b)(6) 2017, and a motor stall with recovery on (b)(6) 2018.The physician was notified and no interventions would be taken as a result of these events.It was unknown if the issue was resolved and the patient was noted as being alive with no injury.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a device manufacturer representative indicated that latest motor stall occurred on (b)(4) 2018 and was confirmed via the logs.It was unknown what the cause of the motor stall was.No further information has been reported.

• 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: 7003397
• MDR Text Key: 92173597
• Report Number: 3004209178-2017-23208
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Date Device Manufactured: 03/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0592-2009
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 80