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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial# (b)(4), product type: programmer, patient.Product id: 8835, serial# (b)(4), product type: programmer, patient.Analysis of the 8835 with serial number (b)(4) revealed no significant anomaly.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was initially received from a consumer on 2019-apr-25 regarding a patient receiving dilaudid (dose and concentration unknown) via an implanted infusion pump.The indication for use was non-malignant pain.It was noted that the patient had cancer and was not real mobile.The patient didn't walk very well and used a walker.This was preexisting and was not related to the device or therapy.It was reported that the patient was unable to successfully deliver a bolus and the remote was not working.The screen came on normally, but the patient would try to deliver a bolus and the remote wouldn't deliver.The patient was not seeing the check mark.The patient had changed the batteries, and at a refill around the first of the year the patient confirmed it was not working because there was a lot of medicine left in the pump, showing that the boluses had not been used.The event was described as having either occurred at the end of early 2018 or early 2019.The event date was unknown (day, month and year unknown).It was further noted that the poor communication icon was seen intermittently at first, and at the time of report it was happening all the time.Communication was attempted without the antenna and the personal therapy manager (ptm) was still not operating as expected.No symptoms were reported related to the device or therapy and no further complications were reported or anticipated.Additional information was later received via a consumer on 2019-may-01.It was reported that the replacement personal therapy manager (ptm) didn't resolve the communication issue.The patient was to follow-up with their healthcare provider to have the pump checked.It was mentioned that the last time the patient was in the physician¿s office getting the pump filled the hcp had pulled out more medication than they were expecting and said something was wrong with the pump.At the time of the report it was confirmed the patient was pressing the correct buttons on the ptm.It was reviewed that the replacement ptm must be coupled with the pump by powering on the ptm and then holding the ptm over the pump and pressing the select key while the ptm was over the pump.The patient however kept getting the poor communication when he did this.It was noted that the patient wasn't around electromagnetic interference and was sure that he was holding the ptm over the pump.The serial number of the ptm was read and it was confirmed at the time of the report the patient was using the correct replacement ptm that was sent to them.The patient¿s medical history included: cancer and walking difficulty / use of a walker.

• 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: 8599764
• MDR Text Key: 145515474
• Report Number: 3004209178-2019-09365
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• 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: 05/01/2019
• Date Device Manufactured: 01/31/2014
• 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