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

Model Number NEU_UNKNOWN_PUMP

Device Problems Application Program Problem (2880); Communication or Transmission Problem (2896); Data Problem (3196)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: a810, serial#: unknown, product type: software, ubd: n/a, udi#: n/a. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a device manufacturer representative (rep) regarding a patient receiving therapy via an implantable infusion pump. It was reported that post new implant when the pump was attempted to be updated the error codes 102 (pump is detected to be in a temporary stop state during interrogation) and 140 (update did not complete) appeared. The caller was advised to exit the application and attempted to update the pump while in stopped mode but the issue remained along with a new error code 114 (pump memory error). The rep was then walked through programming the pump to lowest simple continuous, programming the lowest single bolus possible and enabling the personal therapy manager (ptm). This corrected the issue and rep was able to reprogram the pump successfully. Additional information was received from the manufacturing representative (rep). The rep reached out to the managing physician's office and the office stated the pump was working fine and there were no further issues. The office declined to provide any further information.

• Brand Name: IMPLANTABLE DRUG INFUSION PUMP
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11204718
• MDR Text Key: 227974321
• Report Number: 2182207-2021-00100
• 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: 01/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/08/2021
• 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