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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Bruise/Contusion (1754); Muscle Weakness (1967); Muscular Rigidity (1968); Paralysis (1997); Scar Tissue (2060); Urticaria (2278); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8781 lot# serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.Product id 8781 lot# serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 11-nov-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2021, information was received from a patient via a manufacturer representative (rep).The patient was receiving baclofen (2,000 mcg/ml, 361 mcg/day) via an implantable pump for intractable spasticity.It was reported that the patient had, what they thought was an insignificant fall onto a golf cart last wednesday and after that, they started having some increased spasticity.On thursday, they saw their physician and started also having clonus to left leg along with some weakness of that leg.The patient was admitted for monitoring.They were started on supplemental oral baclofen.On friday, the patient also complained of urticaria.Per the patient, a ct scan was performed last friday that showed the catheter in the correct spot.The patient was ordered for a dye study on the date of this report.The hcp accessed the catheter access port (cap) and was unable to aspirate the catheter so the dye study was then terminated.The patient was to be transferred to a sister hospital and would have a catheter revision soon.The issue was not resolved at the time of this report.

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 received reported that the cause for the inability to aspirate could not be determined.

Event Description

It was reported that patient's wife stated the patient was having really bad spasticity being stuck in a wheel chair.Patient then mentioned patient's wife then mentioned their husband was in the hospital for little over a month because the catheter clogged (aug-10th or 11th), then they went through baclofen withdrawal, had the catheter replaced.It was reported that during the process due to scar tissue the patient ended up having an l1-l2 contusion and ended up with paralysis.Troubleshooting was not required.The troubleshooting steps that were taken on the call resolved the issue.Caller stated the catheter was replaced.

Manufacturer Narrative

Concomitant medical products: product id 8781 lot# serial# (b)(6) implanted: 2014-12-11 explanted: product type catheter product id 8781 lot# serial# (b)(6) implanted: (b)(6) 2014 explanted: 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

Continuation of d10: product id 8781, serial# (b)(6), implanted: (b)(6) 2014, product type catheter product id 8781, serial# (b)(6), implanted: (b)(6) 2014, 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.

• 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: 12339206
• MDR Text Key: 267164387
• Report Number: 3004209178-2021-12603
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2021
• Date Device Manufactured: 02/05/2021
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 88 KG