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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017.Product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 20-jan-2019, udi#:(b)(4).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 morphine via an implanted pump.The indication for pump use was non-malignant pain.The patient reported that in the summer of 2021 she started getting really bad pain and would be in pain for about 6 months, constantly and continuously, and then the pain would go away, and she could have a life.About 6 months ago, the pain was constant, and she was in pain daily.She stated that now she was confined to her home, she couldn¿t drive anymore, the pain was so bad.She had been in and out of the er (emergency room) because of being in so much pain and they would give her a shot of morphine and it did nothing and they would give her a shot ¿of something else¿ and it would relieve the pain for a while.She stated that in (b)(6) 2022 she was in the hospital for 10 days because her blood pressure was ¿210 over whatever¿ and she was in so much pain she couldn¿t walk and would just scream because of the pain.She stated that nothing was working, and the pain was so bad and that she was too weak and couldn¿t stand up.In (b)(6) of 2022, a doctor checked the pump, and they told her there was some scar tissue at the tip of the catheter, but the medication was going through the scar tissue, and they were not seeing any reason for her pain.Her managing physician referred her to another doctor 2 hours away because the managing physician would only use morphine in the pump and the doctor she was referred to, would be able to use dilaudid in the pump.The patient requested and was sent physician listings during the call.She stated that the pain had gotten so bad, and it was not helping with any of the pain and if she couldn¿t find a doctor to put a different medication in the pump then she would rather have it removed.She mentioned that she had 10 spinal fusions that messed her up.

• 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: 16378180
• MDR Text Key: 309563965
• Report Number: 3004209178-2023-02108
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2023
• Date Device Manufactured: 12/13/2016
• 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: 58 YR
• Patient Sex: Female