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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)

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

Event Date 03/06/2017

Event Type  malfunction  

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 consumer on (b)(6) 2017 regarding the patient's implanted infusion pump containing fentanyl (dose and concentration unknown).The indications for use included non-malignant pain and chronic low back pain.It was reported that the patient underwent magnetic resonance imaging (mri) on (b)(6) 2017.The mri was reportedly performed to check the patient's c-spine and t-spine after a car accident in (b)(6) 2016.The mri was not related to the device or therapy.The patient heard the pump alarm, and her personal therapy manager displayed error code 8476, indicative of a motor stall.The mri took place 15 minutes prior.The patient was to follow-up with a healthcare provider to have the pump interrogated and to verify that the pump started back up as expected.No patient symptoms were reported, and no further complications were reported or expected.

Event Description

Additional information was received from a consumer (con) on 2017-apr-18.It was reported that the patient called their healthcare professional (hcp) to make sure the motor stall that was observed on (b)(6) 2017 was resolved.It was reported that the pump reset (recovered) on its own.The motor stall had been resolved.

Manufacturer Narrative

Review of this mdr and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.

Event Description

Additional information was received from the healthcare provider on 2017-jun-05.It was reported that it was unknown what troubleshooting was performed or what actions/interventions were taken regarding the motor stall.The hcp confirmed that the patient informed him of the stall, and telemetry confirmed that the stall occurred on (b)(6) 2017 at 09:00.Recovery occurred on (b)(6) 2017 at 10:28.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6439105
• MDR Text Key: 71050055
• Report Number: 3004209178-2017-06478
• Device Sequence Number: 1
• Product Code: LKK
• 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: consumer,health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• Date Device Manufactured: 09/26/2012
• 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: 47 YR
• Patient Weight: 103