MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Pumping Stopped (1503); Failure To Service (1563); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Fall (1848); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 01/18/2018

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 patient who was receiving morphine (unknown), at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient was told by the nurse that his pump may break because the alarm was going off.The pump was alarming with a dual tone alarm.The patient missed a scheduled refill; the office told him he was scheduled for a refill on (b)(6) 2018 but he did not recall that.He would follow up with his healthcare provider and was scheduled for a fill (b)(6) 2018 at 9:30 am.The patient was hurting a little bit and couldn't stay up on his feet for very long; he would be alright if he stayed in the recliner.No further complications were reported.

Manufacturer Narrative

Updated for the verbatim's "1-6 vertebra was like the snake river," "was a real mess," and "in agony." if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer, indicating that the patient was in agony.It was a month later, and nobody seemed to be doing anything about it.The device manufacturer was going to get in touch with him and get him "going here" at the hcp's office.The patient could not make it one day, when they were all set up to be done in february.He was "sick as a dog" and ended up in the hospital.The patient was "a real mess" and was requesting to "reset that thing at the hcp's office." no further complications were reported.

Manufacturer Narrative

Patient code (b)(4) was used for the verbatim "1-6 vertebra is like the snake river." if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer, further indicating that the patient missed a refill.He noted that he heard beeping two days after he was supposed "to be filled." he was going around the house unplugging things because he did not know that "it was him." the patient did not hear the beeps all the time.The patient reported that he was hurting and "it" was not working (b)(6) 2018 or (b)(6) 2018 and "it" was still hurting after he was filled.The patient reported that he could not walk to the mailbox and that "1-6 vertebra is like the snake river." the patient screamed and dove into the recliner after twenty minutes of standing.The patient reported information about the pump going dry and being in terrible pain.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from patient.The patient again requested assistance and reported that his pump shut off on (b)(6)2018.The patient reported that he was without morphine and could not even walk.The patient reported that he was unable to make a planned meeting with a manufacturer representative (rep) because he was in the hospital and had no way of contacting the representative.The patient again requested assistance in increasing his medication as his pain was "too great", similar to his pain prior to implant.Patient stated "im dying here, i can't walk, i can't do anything".The patient stated he hurt so bad every time he got up he had to go jump in the chair as he couldn't be up for more than 15 or 10 minutes.The patient was requesting a call back.No further complications were reported.

Manufacturer Narrative

Upon further review of the event after updates received on (b)(4) 2018 and (b)(4) 2018 it was determined that the report of the patient "ended up in the hospital" was alleged as related to the device or therapy.Upon further review of the event after updates received on (b)(4) 2018 and (b)(4) 2018, it was determined that the verbatim "1-6 vertebra was like the snake river" no longer applies, and was removed from (b)(4).(b)(4) remained coded for the verbatim "was a real mess." if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer, further indicating that he "screwed up" and did not get his pumped filled on time.The patient did not know he had missed an appointment with his healthcare provider (hcp) and did not figure it out until (b)(6) 2018.Then, it dawned "on him that is him." he heard beeping going off and did not know where it was coming from.The patient stated that he noticed it "kept beeping" on (b)(6) 2018.The patient did have a refill since (b)(6) 2018.The pump was beeping right until it was refilled.The patient reported that he had problems with the pump.The patient requested to speak with a device manufacturer representative because "it's not working right." the patient noted that the pain was "really bad." the patient reported getting refills every 3.5 months, but the pump was not working and it was not "killing the pain." the patient had terrible pain and could not stand up.The patient said that if he was standing 20 minutes he was screaming in terrible pain and had to get off his feet immediately.It was noted that the pain and not being able to stay on his feet did not resolve because of the missed refill appointment.The patient got the pump filled on (b)(6) 2018, but it was not "killing the pain." the pain was still there "just like the pump is not working." the patient stated that the pain started on the "second date" and his lower back started on (b)(4) 2018 and he was due for a refill on (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Additional information was received from a patient.It was reported that the patient still had not had his pump fixed.The patient stated he was sitting there with a morphine pump in his stomach and that the healthcare provider (hcp) did not know that the noise the pump made meant something.The patient found something that describes what happens when the pump was broken, empty, and "all that and the different sounds." the hcp supposedly filled the pump in (b)(6)2018, and the hcp reported that it was not filled.The patient stated that "it did not make that noise" and "it is not working" and his legs were "killing him." the patient reported that it was about (b)(6) and the patient was still without morphine and he had the morphine pump and morphine for about four or five years.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was further reported that the patient had a refill scheduled on (b)(6) 2018, but he was not sent a reminder, so he missed the refill.The patient was "hurting so bad" and had a return of pain.The pump was refilled and the patient was no longer hearing alarms.It was reported that the pump was refilled but was not "turned on." it was further stated that the patient thought the pump was not working because he was "hurting so freaking bad." the patient said that he could not walk due to his back, which started two months prior to (b)(6) 2018, and he needed to "get this taken care of." the patient did not have balance.He would turn fast or walk through a doorway and lose balance.The patient would be sitting and would doze off and drop his glass.The patient was being investigated because he fell too many times.His falls started about two months prior to (b)(6) 2018.He fell about three weeks prior to (b)(6) 2018 when he was chasing an orange that was rolling down the driveway.The patient went head first and just missed hitting the concrete.The patient's memory was also affected, which started the day after the patient's fall about three weeks prior to (b)(6) 2018.The patient reported that he woke up and could not remember what way to turn to get out of the room.The patient noted that the pain was so bad that the patient was "thinking of doing bad things" and he was going out of his mind.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp).It was reported that the issue that was occurring was that the patient was not getting medication.The cause was not determined as they were waiting for testing at the time of the report.The patient was being sent for a radiograph dye study to determine the cause.The patient had not scheduled a dye study at the time of the report, so the cause of the patient not receiving medication had not been determined.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient who reported that he was seen a least 3 weeks ago at which time he was told that the pump was full, but it was not pumping or working right so things would be checked out and he would get a call back, but he had not heard anything yet.The patient didn¿t feel he was getting the help that he needed.The patient again reported the he could not walk anywhere because his legs hurt so bad.He tried to go to the mailbox but turned around.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional was received from the hcp via manufacturer representative.It was reported that the cause of the pump alarm was a low reservoir.The patient had missed their refill appointment.The alarm was silenced; the patient was meeting with a physician to discuss removing the pump, as he felt he no longer needed the pump.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer indicated that at a refill appointment in (b)(6) 2018 there was a volume discrepancy; they pulled out 9ml instead of 2ml.It was reported that the caller could not find a facility to perform a dye study to determine the cause of the discrepancy.The caller stated that the pump was alarming or beeping, it was described as a two-tone alarm every 10 minutes.Per the caller they thought the alarm was the patient's watch at first.It was noted that the patient was no longer using the therapy and had an appointment scheduled in (b)(6) 2018 to discuss removing the pump.The caller reported that they would be meeting with a device manufacturer representative on (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received on 2019-mar-18.It was reported that the patient was taken to the hcp's office on (b)(6) 2019 to get the pump alarm turned off.It reportedly took them two hours to figure out how to turn the alarm off.Three days later, the pump alarm started going off again.The patient was hearing the alarm every 10 minutes which was causing him to be unable to sleep.It was noted that they would be seeing the hcp again in a week (relative to (b)(6) 2019).

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7219932
• MDR Text Key: 98425336
• Report Number: 3004209178-2018-01388
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2019

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 Expiration Date: 09/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 02/07/2018; 02/12/2018; 02/26/2018; 03/09/2018; 02/26/2018; 04/12/2018; 05/14/2018; 05/29/2018; 06/13/2018; 10/01/2018; 10/10/2018; 03/18/2019
• Supplement Dates FDA Received: 02/09/2018; 02/14/2018; 03/01/2018; 03/13/2018; 03/14/2018; 04/16/2018; 05/17/2018; 06/13/2018; 06/14/2018; 10/10/2018; 10/11/2018; 03/29/2019
• Date Device Manufactured: 04/02/2014
• 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): Hospitalization
• Patient Age: 83 YR
• Patient Weight: 123