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

Model Number 8637-40

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

Patient Problems Muscular Rigidity (1968); Tachycardia (2095); Twitching (2172); Chills (2191); Diaphoresis (2452); Insufficient Information (4580)

Event Date 10/02/2022

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient receiving baclofen (unknown dose and concentration) via an implantable infusion pump indicated for intractable spasticity.The consumer stated on sunday (b)(6) 2022, the patient was raising their legs, had cold sweats, was moaning, and with severe spasticity.The consumer stated the symptoms have progressed to the point where they brought the patient into the emergency room.The consumer stated the patient did not have a fever, nor did they have symptoms felt to be related to pneumonia that they have displayed before.The consumer stated the patient's recent symptoms were 'almost identical' to the patient's last episode last year when his pump went dry and the alarm didn't go off.The consumer stated the patient's next refill date was (b)(6) 2022 and requested a company representative to interrogate the pump due to not knowing how much medication was currently in the pump.Consumer mentioned a doctor at the er had the patient's mdt id card and was speaking to someone from mdt at the moment.The consumer mentioned the patient's previous pump amount was getting 'dangerously low', and the pump flipped.At that time, the consumer mentioned their doctor, gave the patient oral medication.When patient services inquired about pump drug, consumer stated patient just has baclofen in it, but they wished they could have baclofen and morphine in their pump like their friend's pump had.Additional information was received that the patient had been exhibiting severe sweating, and muscle contractions.The pump was checked and shown to have 11% of medication in the pump.They stated every time about 2 weeks prior to needing the pump filled, they would go through the same thing.They were not able to get the patient's heart rate lower than 175 and stated they thought he was going to "code out".A physician listing was requested as the patient was not able to travel 4 hours to get the pump filled.Additional information received from the healthcare provider (hcp) via company representative (rep) reported that the patient had a bolus and dye study.The bolus resulted in a small change in decreased spasticity.It was noted that the catheter was intact and patent.The hcp moved the catheter from t1 to t10 and changed dosing.It was unknown if the issue was resolved at the time of report.The patient's weight and medical history were asked and will not be made available.The patient's status at the time of report was listed as "alive - no injury".

Manufacturer Narrative

Concomitant medical products: product id 8780 lot# serial# (b)(4) product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 06-aug-2021, 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.

• 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: 15715675
• MDR Text Key: 302863027
• Report Number: 3004209178-2022-14390
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: 00763000422615
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2022
• Date Device Manufactured: 07/12/2021
• 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): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male