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

Model Number NEU_UNKNOWN_PUMP

Device Problems Difficult to Interrogate (1331); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

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

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: product id: 8840, serial# (b)(4), product type: programmer, physician.(b)(4).

Event Description

On (b)(6) 2015, information was received from health care provider via a representative regarding a patient who was receiving an unknown drug via an implantable pump.The pump serial was not known.The concentration, dose, lot number, medical history, and concomitant medications were not provided reported as unknown.On (b)(6) 2015 an error code "08:08:s8:f:-544 (253) occurred.The health care provider confirmed that there was difficulty with telemetry and communicating with the patient's pump.The code had appeared during the update and the infusion mode went to "stopped pump." troubleshooting included turning the physician programmer off and on and this resolved the issue.The health care provider was able to successfully reprogram and update the pump after starting a new programming session.There were no patient symptoms or therapy issues.The programmer was not being returned.Additional information was requested to verify the patient medication details, indications for use, and specific reason for the incomplete telemetry stopped pump.Should additional information be received a supplemental report will be filed.

• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5162520
• MDR Text Key: 29009380
• Report Number: 3007566237-2015-03030
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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
• Date Manufacturer Received: 09/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1