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

Model Number 8637-40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Lethargy (2560)

Event Date 12/06/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider regarding a patient who was receiving dilaudid (hydromorphone) via an implantable pump for non-malignant pain.It was reported that the patient was admitted to the hospital on (b)(6) 2022.They were experiencing extreme lethargy, unable to stay awake.The healthcare provider (hcp) wanted to make sure the pump was working properly and that the patient was not getting too much medication.The patient had just switched providers but did not have name of new physician.They were transferred to nas (national answering service) so a representative could come and interrogate the pump.

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 was received from a patient representative, which indicated that the patient was in the hospital for over a week due to covid and, on (b)(6) 2022, the patient stated that they heard a single tone alarm coming from the pump.It was noted that the pump needed to be refilled soon.The reporter had not heard the alarms and was wondering what the alarms were.The reporter had been trying to reach the doctor since 2022-12-12 but he was not in office and, per the clinic, only did pump refills on fridays.The patient did have an appointment on friday, (b)(6) 2022 for a pump refill.The refill date was initially scheduled for (b)(6) 2023.The patient was reporting severe back pain and was afraid that the pump was not working.The patient's emergency room (er) doctor told them that the back pain could have been from covid or from the patient laying on her back for a week in the hospital.The patient went to the er on (b)(6) 2022 and was told that they could not get the pump filled at the er.The patient's er doctor gave the patient "a shot" of dilaudid and prescribed percocet every six hours.At about 4am on (b)(6) 2022, the patient stated that their back did feel better.The patient representative was wondering if the patient should continue with the perocet.It was noted that when the patient was in the hospital, magnetic resonance imaging (mri) was done and a manufacturer representative (rep) interrogated the pump to ensure that the pump restarted as programmed.The reporter requested that the pump be interrogated to be checked and to see how much medication was left in the pump.At the time of the report, the issue was not resolved.The reporter was redirected to the healthcare provider to further address the issue.The reporter was provided with information on pump alarms.

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.

• 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: 15979544
• MDR Text Key: 305449913
• Report Number: 3004209178-2022-16416
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Date Device Manufactured: 10/23/2020
• 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: 60 YR
• Patient Sex: Female