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

Model Number 8637-40

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)

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

Event Date 05/22/2018

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 dilaudid (concentration and dose unknown) via an implanted pump for non-malignant pain.However, it was reported the patient was at ¿1.0 continuous¿ (no further details about regular dose).The ¿8286¿ empty reservoir code was seen on the personal therapy manager (ptm) on the date of this report.It was noted the patient was due for a refill and the refill was missed.The patient had open heart surgery on (b)(6) 2018 and because she was in the intensive care unit (icu) she did not have the scheduled refill on ¿(b)(6) 2018.¿ it was noted the patient spoke to the hcp office before and had a refill scheduled for (b)(6) 2018 and was told that the medication should last until then.The reporter was redirected to the healthcare provider (hcp) for refill and would give them a call right away.Patient symptoms were not reported.The patient did allege the pump was alarming last night on (b)(6) 2018; however, it was not as consistent as she remembered, thought that it beeped every 15 minutes.There were no further details about the alarm.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: 7545014
• MDR Text Key: 109516938
• Report Number: 3004209178-2018-11892
• 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: Other
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• 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: 05/23/2018
• Date Device Manufactured: 03/03/2014
• 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
• Patient Age: 51 YR