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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Information was received from a consumer regarding a patient receiving dilaudid via an implantable pump.The indication for use was non-malignant pain.The patient was calling today as the company representative went to the hospital today to interrogate the pump and they were told to call the manufacturer to find out why the pump failed.The patient stated they were currently in the hospital and states she thinks the pump failed on 27-jan-2023.The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

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.

Event Description

Additional information received from the healthcare provider.The patient could not have the pump filled until a couple days later due to fluro guidelines.The cause was asked but was not answered.The pump was filled in the hospital due to her being in patient.The pump was active and working.

Manufacturer Narrative

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.

Event Description

Additional information received indicated that, since the middle of october 2022, it had "been a living hell".The patient had started going to the hospital because the pain was "so intense" and they "couldn't stand it".The patient's blood pressure "went way up".The patient then went home and went back again.The patient saw a doctor who was supposed to "drain" the pump and catheter and put new medication in.The doctor tried four different times to drain, but "it wouldn't", so the doctor told the patient to come back "the following tuesday and he had an x-ray machine".The patient then left the office and, when they left, they could tell that "things weren't right".The patient's pain started increasing until the following morning.It was noted that the patient had just gotten out of rehab and was doing well.The patient went directly to the clinic from rehab.After the patient got the medications out and left, the patient starting getting "a lot of pain increasing" until approximately 10am.The patient called 911 and was taken back to the hospital.It was stated that "then it got really bad because if felt like someone turned the pain pump off".The pump alarm was turned off but there wasn't any medication in the pump.It was stated that "he said there never was", but the patient went through withdrawal and severe pain.It was "horrible, so they had to add the dilaudid".The patient "got up to the point where i was taking three of the vials of dialudid every two hours and increased oral oxycodone from 7.5 every 4 hours to 20mg every 3 hours".It was clarified that the pump never alarmed and it was stated that "when you set up the next appointment, they give you a date that you have to come in by and they have an alarm date and you don't want to push that".It was stated that the patient knew that the pump was "obviously empty".The nurses gave the patient the medication "around the clock" and, if they didn't, the patient went into withdrawal.It was noted that the patient's current primary care provider was very upset with how another doctor managed the pump.It was stated that "they thought it was just me, that i couldn't handle the pump and i was just too much of a whiner".It was stated that "when you have that kind of pain, you're not a whiner".The patient's doctor "finally came to the hospital on thursday morning at 7am and he drained the medicine out and put new medicine in".The pump was checked and "they said it was fine".After that was done, the patient went home.The patient was home for "probably 3-4 days", then had to go back to the hospital because of extreme muscle spasms.It was stated that "they did all these tests at the hospital".The doctors and nurses said "it's the pump".The patient's hospital doctor put the patient on "a healthy dose" of dilaudid every four hours and stopped the "oxy".It was stated that "if the pump worked correctly, i wouldn't have to have that".The reporter was unable to clarify event dates.The patient's hospital doctor discharged the patient and recommended a doctor, who the patient planned to see on 2023-03-03.The patient's hospital doctor had the patient on a high dose of dilaudid, but the patient was "trying to get in sooner" to the new doctor.During the call to technical services, the patient stopped the call to take oral medication.The patient was sent physician listings and was redirected to a healthcare provider.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16281853
• MDR Text Key: 308607642
• Report Number: 3004209178-2023-01474
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634094
• UDI-Public: 00763000634094
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2023
• Date Device Manufactured: 09/15/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 101 KG