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 Dysphagia/ Odynophagia (1815); Fatigue (1849); Itching Sensation (1943); Pain (1994); Urinary Retention (2119); Numbness (2415); Skin Tears (2516); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 04/15/2022

Event Type  Injury  

Event Description

Information was received from a patient who was receiving bupivacaine (1.5 mg/ml at 0.267 mg/day), dilaudid (6 mg/ml at 1.0682 mg/day), and clonidine (10 mcg/ml at 1.78 mcg/day) via an implantable pump for unknown indications for use.The patient reported having an extensive history with pain and stated that they are exhausted all the time, face is numb, cannot swallow, "can't walk", tired all the time, "cuts everywhere", takes a bolus and goes to sleep, "dopey", and the oxy makes their "nose itch".The patient stated that they want to go before a judge and lawyer and take their rights to make the choice to put fentanyl in the pump.The patient stated no longer having pain pills but still have pain.The patient stated being in pain constantly and cannot swallow or pee.The patient threatened to take their life multiple times.The patient additionally reported getting code 338.The patient stated being locked out because of a bridge bolus.It was reviewed that a physician bolus in progress will lock the patient out for the duration of the bridge and the patient stated that they believe they have 62 hours to wait.The patient stated recently seeing their healthcare provi der to confirm this.The patient noted that their healthcare provider cut the dose of the clonidine in half to help with the sleepiness with boluses.

Manufacturer Narrative

Concomitant medical products: product id a820, product type software.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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: 14357069
• MDR Text Key: 291387616
• Report Number: 3004209178-2022-06041
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2022
• Date Device Manufactured: 10/15/2021
• 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: 66 YR
• Patient Sex: Male