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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598, serial#: (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2020, product type: catheter.Product id: 8709, serial#: (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8598, serial/lot #: (b)(4), ubd: 21-sep-2007, udi#: (b)(4).Product id: 8709, serial/lot #: (b)(4), ubd: 14-dec-2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal unknown baclofen 2000 mcg/ml at 440 mcg/day via an implantable infusion pump.The reason for call was the hcp wanted to know how to pull logs from the pump using the 8840 clinician programmer.It was noted there were no events going back to (b)(6) 2020.It was further reported the patient had been experiencing intermittent increases in spasticity.On (b)(6) 2020, the catheter was revised, but issues persist.It was reported the patient¿s spasticity was worse in the mornings.The hcp did not have refill volume information as it was with a different provider but they would look into it.This issue began 4-5 months ago and again was not resolved by catheter revision.The patient reported not hearing any pump alarms and logs that reveal the most recent history showed no events.The issue was not resolved through troubleshooting.The hcp would continue looking into the issue.

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 via a consumer.The patient¿s wife reported that the patient is in terrible shape.It was noted that they don't think the pump was working because the patient can barely move.The patient has had problems with the pump since it was originally put in (implanted (b)(6) 2017) and they had been back and forth to doctors.It was noted that they had replaced the catheter a year or so and again and things had improved.They then started upping the dose and then it was too high, then it was too low.Now they had increased it, but patient was getting worse.The date (b)(6) 2021 is considered an approximate date of event (specific month and year known only).It was further reported that the patient's muscles were so tight that he can hardly walk.They were going every week to the doctor and finally a week ago the doctor said he was going to make the arrangements for the testing.It was stated that a manufacturer representative needed to be present per the healthcare provider.The patient was scheduled to have a roller and dye study performed on (b)(6) 2021.The patient was currently receiving baclofen of an unknown concentration at an unknown dose rate.

• 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
• MDR Report Key: 10547331
• MDR Text Key: 207372974
• Report Number: 3004209178-2020-16139
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR