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); Insufficient Flow or Under Infusion (2182)

Patient Problems Muscular Rigidity (1968); Insufficient Information (4580)

Event Date 12/15/2021

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving baclofen (500 mcg/ml at a continuous dose rate of 150 mcg per day) via an implantable pump.It was reported that a volume discrepancy was observed during a normal refill procedure on (b)(6) 2022.The expected pump reservoir volume was 5.8 ml; however, 0 ml was emptied by the healthcare provider.The pump appeared to be completely empty.The last refill had occurred on (b)(6) 2021 and the low reservoir alarm was set at 2 ml.The low reservoir alarm was expected to ring on (b)(6) 2022.The patient described a resurgence of spasticity approximately around (b)(6) and clinical signs of withdrawal.The date (b)(6) 2021 is considered an approximate date of event (specific month and year known only).No abnormal system event was registered in the pump journals.No environmental factor causing over-infusion had been identified.The pump remained implanted / in-service.No surgical intervention had occurred and no surgical intervention was planned.The next appointment was to occur in on month to measure for volume discrepancy.The low reservoir alarm was now sent at 2 ml and should occur on (b)(6) 2022 (125 days).It was indicated that they should retrieve approximately 31 ml of baclofen in the pump on (b)(6) 2022.For now, they were to monitor if there is a dysfunction or not.The healthcare provider had programmed the pump with the same dosage and would monitor for clinical signs on the patient to ensure no overdose.The issue was not resolved as of (b)(6) 2022.Pump replacement is set for (b)(6) 2024.The date of pump implant was unknown / would not be made available.The patient's medical history, age, and weight at the time of the event were unknown or would not be made available.

Manufacturer Narrative

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 was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) on (b)(6) 2022.It was reported that prior to the refill on (b)(6) 2022, the pump was filled with 20 ml and was programmed to contain 20 ml.It was also reported that the pump was checked again around (b)(6) 2022, which the rep was not present for.As the pump device replacement indicator date was in less than 12 months, the hcp decided to replace the pump.The rep was also not present for the replacement was unable to collect the device for analysis.The cause of the volume discrepancy, return of spasticity, and withdrawal were not determined, but these issues were considered resolved.

Event Description

Additional information was received from the foreign healthcare provider (hcp) via the manufacturer's representative (rep) on (b)(6) 2022.It was reported that another volume discrepancy was observed during the pump check that occurred on (b)(6) 2022.The pump was replaced in (b)(6) 2022.

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: 13315631
• MDR Text Key: 292053215
• Report Number: 3004209178-2022-00955
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 03/25/2022; 03/31/2022
• Supplement Dates FDA Received: 03/28/2022; 04/04/2022
• Date Device Manufactured: 02/01/2017
• 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): Required Intervention
• Patient Sex: Male