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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Vomiting (2144); Dysphasia (2195); Weight Changes (2607); Dysuria (2684); Constipation (3274); Insufficient Information (4580)

Event Date 10/28/2022

Event Type  Injury  

Event Description

Information was received from a patient who was receiving unknown morphine drug (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that "since implant, this thing has caused me nothing but pain." the patient stated that the pump was "on but very low" the patient reported constant headaches due to "air got into my brain during implant, "neurocephalis,' the pain got worse, constantly vomiting, and no appetite because the morphine numbed his insides." the patient reported 12 pound weight loss, not urinating, constipation, and was in so much pain.The patient stated "my memory is shot - i'm losing words it's like i lost a memory, and i have slight pain around my temple and eye socket." the patient has gone to the er (emergency room), got ct (computed tomography) scan done, and a blood patch at the er but their pain got worse.The er put in an iv (intravenous) and gave the patient fentanyl for pain.The patient reported taking oral oxycodone/acetaminophen and migraine medication.The patient mentioned getting a "neck injection to try and help the nerves," which did not resolve the issue.The patient also mentioned that they tried calling their healthcare provider because they ran out of pain medication on monday ((b)(6) 2023) and their next appointment was (b)(6) 2023.The patient requested their pump to be permanently disabled.

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.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 consumer (con) regarding magnetic resonance imaging (mri) compatibility.The patient re-reported their adverse reaction.The healthcare provider (hcp) put the pump at the 'lowest setting.

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: 16158653
• MDR Text Key: 307298675
• Report Number: 3004209178-2023-00604
• 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
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/30/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male