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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphasia (2195); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who was receiving baclofen (250 mcg/ml at 179.9 mcg/day) and prialt (7 mcg/ml at 5 mcg/day) via an implantable pump.It was reported that in the course of concentration or dose increase of prialt, several pump fills were performed within approximately 2 months.It was indicated that in some fillings there were noticeable high differences between telemetered (expected) and aspirated (actual) volume.Regarding (b)(6) 2021, the pump was filled with 40 ml and the expected residual volume (erv) was 18.9 ml and the actual residual volume (arv) was 16.0 (difference of 2.9 ml).Regarding (b)(6) 2021, the pump was filled with 20 ml, and the erv was 16.2 ml, and the arv was 15.0 (difference of 1.2 ml).Regarding (b)(6) 2021, the pump was filled with 20 ml and the erv was 14.9 ml, and the arv was 13.5 (difference of 1.4 ml).Regarding (b)(6) 2021, the pump was filled with 20 ml and the erv was 8.3 ml, and the arv was 7.8 ml (difference of 0.5 ml).Regarding (b)(6) 2021, the pump was filled with 40 ml and the erv was 37.3 ml, and the arv was 34.5 ml (difference of 2.8 ml).With unclear neurological situation with slurred speech and delirium, the patient was admitted to the neurology clinic on (b)(6) 2021.It was noted that the cause could be an overdose of prialt, but possibly also in connection with the pump running too fast.It was further reported that at this point that the patient had already had similar doses of prialt without symptoms before the pump was changed, and that there could be other reasons on the part of his neurological disease why this clinical condition occurred.As a first measure, prialt was removed from the pump mixture.The issue was not resolved as of (b)(6) 2021.A replacement of the pump was planned.The pump was to be sent to the manufacturer for analysis.The patient's medical history was requested but would not be made available.

Event Description

Additional information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) on 2021-oct-26.It was reported that the pump was replaced on (b)(6) 2021.Prialt was also removed from the pump and, as a result, the slurred speech and delirium issue was resolved.

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

Correction: the device code a24 was previously applied in error.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: 12689669
• MDR Text Key: 278147921
• Report Number: 3004209178-2021-15841
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80