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

Model Number 8637-20

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

Patient Problems Muscular Rigidity (1968); Scar Tissue (2060); Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial# (b)(4), product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 02-sep-2023, udi#: (b)(4).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

Information was received from a foreign healthcare provider (hcp) via a distributor regarding a patient receiving gabalon intrathecal at a dose rate of 250 mcg via an implantable infusion pump for spinal cord injury.Past medical history or history of side effects was none.Concomitant medications were unknown.It was reported that the patient experienced worsening of spasticity.The date of the event was described as around early (b)(6) 2022.The date (b)(6) 2022 is considered an approximate date of event (specific month and year known only).Regarding a progress note dated (b)(6) 2022, it was indicated that the effect on spasticity became insufficient around the beginning of (b)(6), so currently the dose had been increased to 250 mcg.When the refill was performed on (b)(6) 2022 and the pump¿s operability was checked, no abnormal variability was observed.However, a catheter contrast study was attempted on (b)(6) 2022 and the drug could not be aspirated from the catheter.The contrast study was discontinued.Afterwards, a single bolus (50 mcg, 6 minutes) was administered and it was decided to observe the condition.If no effect was observed, the effect was to be confirmed with the screening drug.Regarding an attending physician¿s comment, it was indicated that there may be a possibility of catheter trouble, but the cause was unknown.A pump operability test was performed, a rotor test was not performed.The outcome of the event was not recovered.Causal relationship of the event with the drug was indicated as being unrelated.Causal relationship of the event with the pump, programmer, or procedure was noted as none.It was unknown if there was a causal relationship of the event with the catheter.

Manufacturer Narrative

Continuation of d10: product id: 8781.Serial#: (b)(6).Explanted: (b)(6) 2022.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.

Event Description

Additional information was received from the foreign healthcare provider (hcp) via the distributor on 2022-jun-24.It was reported that the lumbar screening drug was performed and was effective.On (b)(6) 2022, the catheter passage was confirmed using contrast agent in a visual field, a catheter x-ray study, for a catheter replacement.While using the contrast agent, the formation of the membrane was confirmed at the catheter tip, th7.It was suggested that an accumulation of drug solution in the membrane resulted in the failure of the drug solution to reach the intrathecal space.Backflow of cerebrospinal fluid was checked and the catheter was replaced.The adverse event of worsened spasticity was considered resolved as of (b)(6) 2022.

Event Description

Additional information was received from the foreign healthcare provider (hcp) via the distributor on (b)(6) 2022.The catheter would not be returned to the manufacturer for analysis as it had been discarded.

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

Continuation of d10: product id 8781, serial# (b)(6), implanted: (b)(3) 2022, explanted: (b)(3) 2022.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.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 the foreign healthcare provider (hcp) via the distributor on 2022-jul-05.As of (b)(3) 2022, the patient¿s progress was good after catheter replacement.The outcome of the event was recovered as of (b)(3) 2022.Regarding the physician's opinion on the cause of the formation of the membrane, the cause was unknown but there is no causal relationship with gabalon intrathecal.

• 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: 14794013
• MDR Text Key: 303231349
• Report Number: 3004209178-2022-08067
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• 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: 07/07/2022
• Date Device Manufactured: 11/01/2021
• 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...."; SEE H10....; SEE H10....
• Patient Outcome(s): Required Intervention
• Patient Sex: Male