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

Model Number NEU_UNKNOWN_PUMP

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

Patient Problem Malaise (2359)

Event Date 05/15/2018

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 healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving in fumorph (10mg/ml at 2. 213mg/day) via intrathecal drug delivery pump. The indication for use was not noted. It was reported that alarms were heard, but not clinician programmer was available. The hcp believed the pump was empty. The patient neglected to come in to any of her refill appointments. The patient reported feeling miserable. The hcp was pretty sure the pump was empty, given the low reservoir alarm (lra) was set to sound on (b)(6) 2018. The low reservoir volume was set to 2ml. Based on the flow rate, the reservoir would be expected to be empty about 9-10 days after the low reservoir alarm. The patient was in between managing hcps, her managing physician had left the clinic. There were no further complications reported at this time.

• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7656325
• MDR Text Key: 113005439
• Report Number: 3007566237-2018-01949
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/19/2018
• 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