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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)

Patient Problems Granuloma (1876); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Pain (1994); Therapeutic Response, Decreased (2271); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 17-may-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving compounded baclofen 400 mcg for a total dose of 159.90746 mcg/day, fentanyl 100 mcg for a total dose of 39.97687 mcg/day, and clonidine 400 mcg for a total dose of 159.90746 mcg/day via an implantable pump for spinal pain.It was initially reported on (b)(6) 2020 that the patient reported increased spasms and stiffness since their last pump refill.The patient was started on oral baclofen.The outcome of the event was noted as ongoing.The clinical diagnosis was decreased therapeutic relief.The event date was (b)(6) 2020.The etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was not related.The relatedness to the drug (baclofen) was possibly related and the drug action that caused the event was no change in drug.No further complications were reported.Additional information received from a healthcare provider via a clinical study on 2020-jul-29.It was reported the patient had ongoing increased, severe whole-body pain on (b)(6) 2020.The patient was scheduled for a telehealth visit secondary to covid-19.The patient was started on tizanidine on (b)(6) 2020.An it adjustment visit was offered to the patient, but the patient elected to wait until their scheduled pump refill appointment.The patient again had persistent pain on (b)(6) 2020 and the pump was reprogrammed to deliver a complex continuous/flex rate.The daily dose was increased.On (b)(6) 2020, the patient reported ongoing pain.They were scheduled for an it rate adjustment.On (b)(6) 2020, the patient reported worsening pain through their lower back and bilateral lower extremities.The intrathecal rate was increased on (b)(6) 2020.Additional information received from a healthcare provider via a clinical study on 2020-oct-15.Regarding etiology, the relationship of the event to the device or therapy was possibly related and the relationship of the event to the implant procedure was not related; the event was related to drug (baclofen) and the drug action that caused event was no change in drug.Additional information received from a healthcare provider via a clinical study on 2020-oct-22.On (b)(6) 2020 the patient reported new upper and lower bilateral extremity numbness.An x-ray on (b)(6) 2020 revealed an inflammatory mass / possible granuloma, but they were unable to delineate if it was at the catheter tip.They ordered acervical mri (magnetic resonance imaging) and the intrathecal rate was increased 20% on (b)(6) 2020.The patient was to be scheduled for surgical catheter revision.Regarding etiology, the relationship of the event to the device or therapy was related and the relationship of the event to the implant procedure was not related; the event was related to drug (bupivacaine) and the action that caused event was an increased dose.The event was ongoing.Additional information received from a healthcare provider via a clinical study on 2020-oct-23.On (b)(6) 2020 the patient reported persistent pain.Reprogramming occurred on (b)(6) 2020.The patient also reported persistent pain on (b)(6) 2020.On (b)(6) 2020 a catheter dye study was attempted, and they were unable to aspirate catheter via the catheter access port (cap).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from an hcp via a clinical study indicated that the device diagnosis was catheter occlusion.

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 healthcare professional (hcp) via a clinical study reported on (b)(6) 2020 a magnetic resonance imaging (mri) with contrast revealed no sign of inflammatory mass.On (b)(6) 2020 a magnetic resonance imaging (mri) without contrast revealed no sign of inflammatory mass.On (b)(6) 2021 surgical intervention occurred where the catheter was spliced replacing the spinal segment and resolving the occlusion.The outcome of the event resolved without sequelae on (b)(6) 2021.No further complications were reported/anticipated.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported the status of the catheter that was replaced was unknown.No further complications were reported/anticipated.

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 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 healthcare professional (hcp) via a clinical study reported on 2020-(b)(6) a catheter access port (cap) dye study revealed an occluded catheter (unable to aspirate).On 2020-(b)(6) the patient's revision was postponed secondary to covid 19 pandemic.On 2021-(b)(6) there was poor flow noted at the catheter tip.The catheter was spliced, replacing the spinal segment and the catheter tip was repositioned from t4 to t6.On 2021-(b)(6) no numbness was reported.On 2021-(b)(6) there was no improvement and the pump was reprogrammed where the intrathecal (it) rate was increased.On 2021-(b)(6) the patient's pain was managed.The outcome of the event resolved without sequelae on 2021-(b)(6).The relatedness to the event to the device or therapy was related.The device diagnosis was catheter occlusion.No further complications were reported/anticipated.

• 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: 10734821
• MDR Text Key: 216940728
• Report Number: 3004209178-2020-18693
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; SEE H10....
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 73