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

Model Number SYNCHROMED II 40L

Device Problem Failure to Deliver (2338)

Patient Problem Pain (1994)

Event Date 11/22/2019

Event Type  Injury  

Event Description

The medtronic synchromed ii infusion pump is malfunctioning and failing to administer pt-on-demand medication boluses when it is actually appropriate to do so on multiple occasions. For this particular pt, the problem began 3 months ago and when he is in severe pain, he often requests a bolus by pressing a button on his remote. There is no apparent malfunction to the pt, but on many occasions he does not receive the usual expected pain relief. When we interrogate the pump device using medtronic's clinical programmer, we have found multiple listed occasions where the bolus was appropriate to administer (not subject to lock out time period etc. ) but was simply not given for an unk reason. The "session long report" lists that the pt has requested the boluses at a particular time, and at that same time the machine delivered an error stating "bolus requested / bolus rejected" or "88-89" error. The pt is then left suffering, and rationing the remaining boluses they have for the day. They are then left worrying that they have to ration their bolus requests to account for unpredictable malfunctions of the device, and even 'rejected' button pushes count towards their daily limit. This result in significant pt harm. The pt in question came to clinic on (b)(6), and i increased his maximum limit of allowed daily boluses to guard against possible malfunctions of the device in the near future, so he could not be "locked out. " below is a tabulation (by the pt) of all malfunctions of the device over the past 3 months. "you can see that the percentage of dropped boluses varies between 3. 9% and 11. 3% and that there were 4 episodes (5. 3%) over the past (more painful) week. I am hopeful that the epidural steroid injection on monday will help to prolong the interval between boluses and thus to decrease the number of boluses needed and therefore the opportunities for dropping any. From (b)(6) 2019 (9 days of log): 4 episodes on (b)(6) 3:06 am, (b)(6) 5:17 am, (b)(6) 10:28 pm, (b)(6) 10:09 am, 4/76 actuations during that 9 days
=
5. 3% dropped boluses; (b)(6) - (b)(6) (8 days of log): 5 episodes on (b)(6) 5:05am, (b)(6) 5:02 pm, (b)(6) 7:59 am, (b)(6) 6:08 am, (b)(6) 3:44 am 5/77 actuations during that 8 days
=
6. 5% dropped boluses. (b)(6) long log report never generated; (b)(6) - (b)(6) (9 days of log): 3 episodes on (b)(6) 5:37 am, (b)(6) 6:07 am, (b)(6) 3:34 pm, 3/77 actuations during that 9 days
=
3. 9%; (b)(6) - (b)(6) (9 days of log): 3 episodes on (b)(6) 11:34 pm, (b)(6) 3:08 pm, (b)(6) 4:05 pm, 3/76 actuations during that 9 days
=
3. 9%; (b)(6) - (b)(6) (8 days of log): 3 episodes on (b)(6) 3:40pm, (b)(6) 9:32 pm, (b)(6) 7:30 pm, 3/76 actuations during that nine days
=
3. 9%; (b)(6) - (b)(6) (11 days of log): 8 episodes on (b)(6) 6:09 pm, (b)(6) 12:03 am, (b)(6) 3:04 pm, (b)(6) 10:32 pm, (b)(6) 12:03 am, (b)(6) 8:04 pm, (b)(6) 12:05 am, 625 for 50 2 pm, 8/71 actuations during that 11 days
=
11. 3%. (b)(6) 2019 synchromed ii pump interrogation, see above for device malfunction date / times. The pt has a synchromed ii pump connected to an intrathecal catheter to treat severe lower back pain from cancer pain. Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC SYNCHROMED II INTRATHECAL PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 9376223
• MDR Text Key: 168212110
• Report Number: MW5091284
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SYNCHROMED II 40L
• Device Catalogue Number: 863740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/25/2019 Patient Sequence Number: 1