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

Model Number NEU_PTM_PROG

Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problems Pain (1994); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8637-20, serial# (b)(4), implanted: (b)(6) 2010, product type: pump.(b)(4).

Event Description

Information was reported by the consumer regarding their implanted system which was used to deliver morphine (10 mg/ml at 1 mg/day).The indication for use was non-malignant pain and chronic low back pain.Since an unspecified date in (b)(6) 2015, the patient was unexpectedly declined for their boluses doses.The patient was supposed to be able to receive a bolus every 6 hrs but was not receiving all of their boluses.It was noted that the patient was not aware that there were three lockouts associated with them receiving their boluses and when the patient talked to their doctor about it the doctor said thought maybe the pump was empty and that was why the patient was not receiving the intended bolus doses.The patient said that was not the case, the doctor was making excuses, and nothing had been done about the issue.It was also reported that on (b)(6) 2016 the patient pain was severe and when they tried to initiate a bolus does they were locked out for 5hrs 1min.The patient panicked and screamed and yelled so their neighbors called 911 and the patient was taken to the hospital.It was reported that the patient was in the hospital all last week and was given int ravenous morphine and methadone every 3 hrs.It was reported that the patient had a sudden onset of pain on 2016-02-04.The last time they tried to receive a bolus was at 3:30 on (b)(6) 2016, and at 11:30 they tried to request the next bolus due to their pain levels the personal therapy manager (ptm) was showing they had to wait another 6 hrs 1 min.It was noted that the patient was having their pump refilled on that day and sometimes the patient goes "2-3-5" days without receiving a bolus because they are not in pain but then the patient will be locked out when they need the bolus dose.Additional follow-up regarding the device information, if any empty pump was confirmed, if troubleshooting had been done, if any actions/interventions were required, cause of the event, relevant printouts, and resolution of the events was requested.On (b)(6) 2016, information received from staff at the office of the managing physician reported that they did not know if the patient was having difficulties with their ptm on (b)(6) 2016.On (b)(6) 2016, the patient was seen in the office, as they thought their pump had shut down; it was noted that the pump had not shut down, and it was still running.At that time, the patient was given a bolus through the catheter access port (cap) until their pain had been controlled.The pump was reprogrammed, but the nature of the reprogramming was not specified and the printout was not provided.A review of the patient's chart at that time showed that the patient had been in and out of the emergency room (er) for the prior two weeks, and had also been admitted to the hospital; the dates of the er visits and hospitalization were unable to be specified, and the reason for the hospitalization was also unknown to the office of he managing physician.It was further stated that the patient going to the er could have been psychological.The patient's next appointment was scheduled for (b)(6) 2016.As of (b)(6) 2016, the office of the managing physician intended to provide the pump log printouts; no additional information was provided.Additional information regarding confirmation of the bolus lockouts, reason for hospitalization, pump settings, pump logs, confirmation of pump dosing, whether or not the pump medication was being weaned, concomitant medications, pertinent medical history, volume discrepancies or abnormalities observed during the refill on (b)(6) 2016, and device information was requested, but was not provided.

Event Description

Additional information was reported by the consumer on (b)(6) 2016.The patient reported that they hope "this pump works because she had pain so severe she tried to commit suicide." the patient tried to jump off the building but could not get the fire escape open with one arm so she went to the emergency room.It was noted that the patient would use the ptm to bolus once a week.And when they would try to bolus, the pain would remain the same.The patient used methadone as well but nothing helped.The patient reported that their blood pressure went up due to the severe pain.While they were in the er they decided to replace the pump.The healthcare professional (hcp) wanted to do a dye study but could not due to the high dose of gabapentin they were on.The hcp was concerned the gabapentin effected the kidneys so they could not use the dye.The hcp thought there could be a blockage.There was a total system explant on (b)(6) 2016 and the hcp changed the medication from morphine to dilaudid.It was reported that the situation had resolved.

• Brand Name: UNKNOWN PTM
• 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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5480242
• MDR Text Key: 39678450
• Report Number: 3007566237-2016-01186
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_PTM_PROG
• Device Catalogue Number: NEU_PTM_PROG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 00069 YR