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

Model Number 8637-20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Granuloma (1876); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot#: none, serial# (b)(4), implanted: (b)(6) 2016, explanted: none, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 31-aug-2018, 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 morphine 10 mg for a total dose of 2.83744 mg/day via an implantable pump.It was reported on (b)(6) 2019 the patient reported unsatisfactory analgesia.The pump was reprogrammed on (b)(6) 2019.On (b)(6) 2019 catheter evaluation was inconclusive.It was noted the catheter was difficult to observe under fluoroscopy, however dye was injected and confirmed to be present in cerebrospinal fluid (csf).On (b)(6) 2020 the patient reported unsatisfactory analgesia.The outcome of the event was noted as ongoing.The clinical diagnosis was unsatisfactory analgesia.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 (morphine) was possibly related and the drug action that caused the event was no change in drug.The event date was (b)(6) 2019.No further complications were reported.Additional information was received from a healthcare professional (hcp) via a clinical study reported catheter evaluation has been ordered, but not yet performed.No further complications were reported.Additional information received from a healthcare provider via a clinical study reported unsatisfactory analgesia on (b)(6) 2020.A catheter evaluation had been ordered but not yet performed.Additional information received from a healthcare professional (hcp) via a clinical study reported the intrathecal (it) dose was increased by 10.9% on (b)(6) 2021.No further complications were reported/anticipated.Additional information received from a healthcare provider via a clinical study reported that, on (b)(6) 2021, a catheter access port (cap) contrast study was performed and results were normal.Ct scan on same day resulted in abnormal "ct signal".A mri was performed, on 2021-apr-06, which showed a mass on cauda equina around l2-l3, near it catheter following suspicious mass by it catheter tip, provider is awaiting further information on mass origin to proceed accurately with treatment.

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 2021-jun-24 it was noted that no granuloma was present on the computed tomography (ct) scan.The event was noted as ongoing on 2021-aug-04.

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 provider via a clinical study reported that the patient's intrathecal (it) morphine concentration and personal therapy manager (ptm) were increased on (b)(6) 2021.The patient's it dose was increased again on (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021.

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study reported on 2021-nov-29 the patient reported significant improvement.The outcome of the event 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
• 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: 12212878
• MDR Text Key: 265189060
• Report Number: 3004209178-2021-11283
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Date Device Manufactured: 09/21/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 120 KG