MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

Device Problems Improper or Incorrect Procedure or Method (2017); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving unknown drug via an implantable pump for unknown indications for use. It was reported that the hcp saw service code 144. Technical services reviewed the meaning of code as "pump memory error. Invalid pump clock time". It was unknown if the message was seen before or after the update. The hcp thought they updated the pump successfully; however, while in the middle of the first update the batteries died so they had to switch to a different clinician programmer. The rep reported that they assumed the hcp was using the 8840 for initial programming and then those batteries died so they switched to a clinician tablet. Technical services reviewed that this could explain the reason for the code. The rep later reported that the patient was back in the office on (b)(6) 2022 reporting that their pump was not working. The rep reported that the hcp was now seeing service code 140. Technical services review ed meaning of 140 service code as previous update failed and to have hcp check logs and reprogram pump with appropriate settings.

Manufacturer Narrative

Concomitant medical product: product id: a810. 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): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13592362
• MDR Text Key: 286471815
• Report Number: 2182207-2022-00330
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial