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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Filling Problem (1233); Application Program Problem (2880)

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

Event Date 12/13/2019

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 intrathecal unknown morphine (concentration and dose unknown) via an implanted pump for spinal pain.It was reported the 8476 error code was seen on the personal therapy manager (ptm) on (b)(6) 2019.The patient did not recently have an mri.The patient did have the pump refilled on (b)(6) 2019.The patient had not heard a pump alarm.It was also reported the patient had lost 40% of hearing so he did not know if he heard any beeping.It was noted the patient was currently at the healthcare provider¿s (hcp¿s) office on (b)(6) 2019 and he did try to get a bolus about 15 minutes ago and it was successful.Patient symptoms were not reported.The patient called back on (b)(6) 2019 and reported this weekend it seemed his ptm shut down, so he went to his doctor¿s office today and the patient was able to give himself a bolus at the doctor¿s office, but when he went home again, he was seeing the error code 8476 again.It was noted the doctor¿s office checked his pump and saw no records of a motor stall at all but he still was not able to deliver a bolus.It was further reported his actual pain management physician had been on leave for a year, so his nurse practitioner took over the management of his pump.It was also reported that during his refill, the nurse practitioner had made two attempts at refilling his pump and he was wondering if that had anything to do with the motor stall.The patient had went all weekend without his medication.The patient had not been near any electromagnetic interference (emi).It was also reported on the main screen on his ptm he saw a bell for an alarm which he had never seen before.The patient called back again on (b)(6) 2019 regarding the unresolved error code 8476 that began on friday.It was reiterated that while at the hcp¿s office on (b)(6) 2019 the code cleared, the hcp checked the pump and did not see a motor stall in the report.When the patient returned home the code returned and the patient was again unable to request a bolus.The patient confirmed there were no new potential sources of emi in/around his house.At the refill on (b)(6) 2019 it took ¿like three times¿ before being able to successfully fill the pump and the patient was concerned this contributed to the issue.The patient had concerns about medication not being delivered/backing up and estimated end of service (eos).A ptm replacement was offered and it was reviewed this would unlikely resolve the issue and the patient would continue working with the medical office to address the unresolved issue.Additional information was received from a consumer on 2019-dec-18 indicated the patient received the ptm due to not being able to use his ptm because of the error code he was getting previously.The patient was still getting the same error code that was unresolved with the new ptm.The patient was redirected to follow-up with the hcp.No further complications were reported/anticipated or expected.

• 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: 9532380
• MDR Text Key: 173229158
• Report Number: 3004209178-2019-24563
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2019
• Date Device Manufactured: 09/10/2015
• 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: 58 YR