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); Swelling (2091); Cramp(s) (2193); Complaint, Ill-Defined (2331)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, lot#: 0219279794, implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: 0219279794, ubd: 28-sep-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a clinical study regarding a patient who was receiving baclofen at flex dosing via an implantable infusion pump.It was reported that the patient suddenly developed severe spasticity and leg cramps.It was noted that the patient had recently underwent a catheter revision at the end of march with a favorable post-operative course [refer to manufacturer report # 3004209178-2020-06394 for details pertaining to the catheter revision].It was reported that there were no signs of meningitis and that there were no infectious parameters shown during additional lab testing.The dorsal wound showed a subcutaneous swelling, and it was unclear when it had occurred.A ct thorax was performed on (b)(6) 2020 and showed no disconnection of the pump.The pump was interrogated on (b)(6) 2020 and found no problems or alarms.Side-port aspiration was also done on (b)(6) 2020 and liquor [csf] could be obtained quickly with normal cytosis.It was indicated that in consultation with the patient, the pump was increased by 10%.The event had resulted in an emergency room visit.The device diagnosis was reportedly ¿not applicable¿ and the clinical diagnosis was increased spasticity.The etiology of the event was indicated to be related to the device/therapy and not related to the implant procedure.At the time of this report, the outcome was ongoing.Additional information was received.Laboratory testing was performed on (b)(6) 2020; no problem was found.Ct scan with contrast was performed on (b)(6) 2020; it was indicated there was probably something disturbing the diffusion of baclofen.The pump was reprogrammed on (b)(6) 2020.The catheter was repositioned on (b)(6) 2020.The event resulted in in-patient hospitalization.The clinical site concluded the increased spasticity was caused by arachnoid deformities around the catheter tip.Additional information was received.On (b)(6) 2020, the patient presented themselves at urgency, but no abnormalities were found.Additional information was received.The event was ongoing.There was a growth of a kind of a 'web' around the catheter tip, which mainly caused diffusion from contrast to cranial, not to caudal.Why this growth of the deformities happened in this patient was not clear.The etiology of the arachnoid deformities around the catheter tip was updated to not related to the device or therapy.The patient was unable to say whether this swelling was already present or is a new event.The neurosurgeon was not concerned about the swelling and has therefore not investigated it further.Therefore, no actions were taken for the dorsal wound.The swelling remained stable for the time afterwards.

Event Description

Additional information received from a foreign healthcare professional (hcp) via a clinical study reported the relationship of the event to the implant procedure was possibly related.No further complications were reported.

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.

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 repot 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 from a foreign hcp via a clinical study on(b)(6) 2020.It was reported that additional interventions included reprogramming on (b)(6)2020 and medication administration on(b)(6) 2020.

Event Description

Additional information was received from a foreign hcp via a clinical study on 2020-oct-20.It was reported that a revision was performed on (b)(6) 2020.The event was resolved without sequelae on that date.

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 from a foreign healthcare professional (hcp) via a clinical study reported the patient had a selective dorsal rhizotomy on (b)(6) 2021 the outcome was updated to resolved without sequelae on (b)(6) 2021.

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.

• 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: 10098406
• MDR Text Key: 192666799
• Report Number: 3004209178-2020-09313
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/24/2020; 08/20/2020; 10/20/2020; 10/06/2021
• Supplement Dates FDA Received: 06/25/2020; 08/26/2020; 10/22/2020; 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Required Intervention