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

Model Number NEU_UNKNOWN_PUMP

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Type  Injury  

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 an unknown drug at an unknown dose and concentration via intrathecal drug delivery pump.The indication for use was not noted.It was reported that the pump was alarming every 30 minutes and the pump was empty.It was due to be removed in (b)(6) 2018.The pump had not been interrogated to determine the alarm.No symptoms were reported.There were no further complications reported at this time.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep).The rep was unaware of when the pump alarm was first noticed, and did not know the serial number of the device.It was indicated that the rep did not know if the pump was empty, and stated the patient was scheduled to have the device removed (b)(6).The rep instructed the healthcare provider at the mri facility that a rep would need to come interrogate the pump to know why it was alarming, and if it could be scanned.The patient's weight was unknown.

Manufacturer Narrative

The patient's previous identifier "(b)(6)" was removed regarding conflicting information reported regarding the patient's identification.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a healthcare provider (hcp).The hcp didn't know the alarm had gone off, but mentioned it might have happened when the patient was on the floor.He clarified that the alarm was going off when the patient got to the hospital.He also mentioned that the pump was empty and that there was an issue with the battery.The hcp provided the patient¿s last name only, date of birth ((b)(6)), the patient¿s phone number, and her current address they had on file.It was noted that the patient was visiting in (b)(6).The physician's name who placed the patient¿s pump was provided.The hcp had contacted a company representative in (b)(6).The hcp had no further information.

• 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: 7318630
• MDR Text Key: 101857459
• Report Number: 3007566237-2018-00668
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/06/2018; 03/12/2018
• Supplement Dates FDA Received: 03/08/2018; 04/10/2018
• 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 Outcome(s): Required Intervention