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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter; product id 8782, serial# (b)(4), implanted: (b)(6) 2018, product type catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 30-jan-2019, udi#: (b)(4); product id: 8782, serial/lot #: (b)(4), ubd: 29-aug-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving baclofen (unknown dose and concentration) via an implantable pump for intractable spasticity.It was reported the patient has been getting intermittent relief from their itb pump and has had an increase in spasticity, an increase in falls, and bladder spasms.The issue started around (b)(6) 2020.The cause of the event was undetermined.The catheter was access on an unknown date, with reported sluggish return at first that then flowed fine, "as would be expected".The patient was scheduled for pump replacement on (b)(6) 2020.The issue was not resolved at the time of this report.The patient's status was alive - no injury.

Event Description

Additional information was received from the rep on 2020-jun-15.The medication being delivered was 450 mcg/ml baclofen at 50.97 mcg/day (66.01 mcg/day after replacement).Patient also has a ptm with 6/24 activations of 3mcg per day.On (b)(6) 2020, the patient¿s pump was replaced.The hcp was able to aspiratefrom catheter intraop, it was not replaced.In pre-op, the patient mentioned that he thought he has had an increase in spasticity in his legs since after a pocket revision ((b)(6) 2018), and it has then gotten worse recently (2020) with falls and bladder spasms.Pump sent to pathology per account protocol.Rep was able to pick it up on 2020-jun-17 and will return as soon as possible.There were no further complications reported/anticipated.

Manufacturer Narrative

Continuation of d11: product id: 8780, serial# (b)(6), implanted: (b)(6) 2017, product type: catheter.Product id: 8782, serial# (b)(6), implanted: (b)(6), product type: catheter.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.

Manufacturer Narrative

H3: the pump was returned, and analysis found no anomaly.H6: all previously reported method, result, and conclusion codes no longer apply to this event.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.

• 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: 10117139
• MDR Text Key: 196556711
• Report Number: 3004209178-2020-09674
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10....".
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR