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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Failure To Service (1563); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Weight Changes (2607)

Event Date 03/01/2018

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 patient who was receiving dilaudid, morphine, unknown concentration at unknown dose via intrathecal drug delivery pump for spinal pain.It was reported that a medical condition occurred.No interventions were mentioned.The reported symptom was withdrawal.Patient reported that his pump was empty and was hearing a critical alarm.Patient said that he was trying to get in for a refill but was recently given adreol for his attention deficit disorder (add), and took the medicine and prescription to the healthcare professional (hcp) office "to prove i was on aderol because i know it could show up on a urinalysis as methamphetamine but i don't do drugs".Patient said at this point, the hcp told him "they were gonna fill my pump anymore because i had a dirty urinalysis and i told them i brought everything in to prove i got the aderol from my psychiatrist and i don't agree with this".Patient said that he needed his pump refilled because it was empty and had been hearing an alarm.He said that he started hearing an alarm on (b)(6) 2018 and said it was "both the single and the triple beep and now its doing the single beep".Patient said he didn't know when he was supposed to be refilled and said he wasn't sure what day he was supposed to be refilled on (b)(6).Patient said he had been having withdrawal symptoms since (b)(6) 2018.Patient said he went to the hospital and they gave him "vicodin 5 mg" to help with withdrawal.Patient said that sometimes with morphine and sometimes dilaudid and when i asked what medication he last had in his pump he said he thought it was dilaudid.Patient didn't know the dose and concentration of these drugs and thought he last had dilaudid in his 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.The patient's pump alarm was going off every 10 minutes.It felt like someone was poking him in the head since 3 to 4 weeks ago.It was stated the patient could smell burning flesh since 2 weeks ago.The patient had also reported withdrawals starting 2 to 3 weeks ago and it was an every day thing.The patient had also lost 15 pounds since april 2018.It was also noted that the patient had 2 neck surgeries and 8 back surgeries.No further issues were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from manufacturer representative (rep).It was reported that the rep confirmed the motor stall recovery post magnetic resonance imaging (mri) that the patient had and everything was fine there but he also confirmed the empty reservoir alarm occurred on (b)(6) 2018.The rep stated that the healthcare professional (hcp) was not going to do anything with the empty reservoir at this time.The rep stated the pump was programmed to dilaudid 25mg/ml @ 11.787 mg/day and clonidine 250ug/ml @ 117.87 ug/day in flex mode.No further complications were reported.

Event Description

Additional information was received via a consumer.The has had 13 cancer operations, 8 back surgeries, 2 hernias, 1 neck surgery, broke his neck, and has died three times in the past and has seizures.It was further noted that the patient suffers from chronic pain and was in pain still.The pump had been turned off for the last two years because the patient did not have a physician to fill or manage their pump.The old drug in the pump was noted as having been morphine (therapy dates not specified; concentration and dose rate unknown).The patient¿s psychiatrist had prescribed him adderall and the patient had then tested positive for methamphetamines so his managing physician dropped him as a patient.

Manufacturer Narrative

H6 correction/update: the device code c63205 and c63214 were previously coded in error.The device code c62928 is no longer applicable.The previously applied conclusion code 4315 and 92 were replaced with 67.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 7473657
• MDR Text Key: 107344490
• Report Number: 3004209178-2018-09650
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1