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

Model Number 8472-60-10

Device Problems Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Device Displays Incorrect Message (2591)

Patient Problem Rash (2033)

Event Date 01/19/2018

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 professional (hcp) regarding the patient¿s implantable drug infusion device. The drug being delivered was 40 mg/ml morphine (unknown) at 40 mg/day. The reason for use was non-malignant pain and other non-malignant pain. It was reported that the pump refill interval is every 60 days. During the last refill (60 days ago prior to (b)(6) 2018), he felt the needle went in at a steep angle. The hcp believed he was able to fill the pump, however when he drew back the needle there was fluid seeping out. The hcp reported about 5 minutes after the refill a rash developed at the pump site and spread very rapidly up to maybe the chest area. The patient was given benadryl for the rash. The hcp stated that there was no chance it could have been a pocket fill because there were no other negative side effects and the patient¿s pain level has been about the same (no withdrawals). The patient was in for a refill today ((b)(6) 2018) and when they aspirate from the reservoir, he pulled nothing back. The hcp was expecting anywhere from 12-18 ml back during the refill. The pump was checked under fluoro and it looks like the pump is empty as well. The reason for the call is the hcp wants to know if it¿s possible the propellant could have leaked from the pump when he injected the needle at the steep angle. It was reviewed that it would not be anticipated that the propellant is leaking because it is encased in titanium. It was also reviewed that if there was no propellant left in the pump, nothing would push the drug, therefore there should still be drug left. Because there is no drug left, it is another indicator that the propellant did not leak. The hcp stated that there is a possibility some drug went into the pump and some could have gone to the subcutaneous tissues. The hcp was thinking about refilling the pump on the day of the call, and that they may fill the pump with saline. Considerations were reviewed of filling the pump and bringing the patient back earlier to check for volume discrepancy, and to consider dosing as well since it is not known how long patient has been without drug. Additional information was received from an hcp on (b)(6) 2018, when it was reported that the doctor initially filled the pump on (b)(6) 2018 with saline under fluoro and ¿the bellows explanted like expected so he aspirated all 60 ml of saline back. ¿ the hcp was able to fill up the pump like normal on (b)(6) 2018. The hcp was also informed that there was a field action for the pump in regards to refills and potential drug leak from the septum, and the information would be relayed to the doctor. There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the hcp on (b)(4) 2018. It was reported that the cause of the empty pump and volume discrepancy was not determined. It was also reported that the cause of the ¿fluid seeping out¿ was not determined. The patient¿s weight was not reported as it was stated, ¿we don¿t weigh the patients. ¿ there were no further complications reported/anticipated.

• Brand Name: ISOMED
• 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: 7359641
• MDR Text Key: 103159791
• Report Number: 3007566237-2018-00857
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/14/2002
• Device Model Number: 8472-60-10
• Device Catalogue Number: 8472-60-10
• 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: 04/05/2018
• 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