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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)

Patient Problems Nausea (1970); Overdose (1988); Dizziness (2194); Diaphoresis (2452); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was currently receiving baclofen (concentration: 517 mcg/ml, dose rate: 141 mcg/day) and morphine (concentration: 2.3 mg/ml, dose rate:.75 mg/day) via an implantable pump for intractable spasticity.It was reported that the wrong concentration was labeled by the pharmacy.Last friday (b)(6) 2020, they were refilling the pump and wanted a high concentration to lengthen refill cycles.They were notified that the pharmacy had made a mistake and it was the wrong concentration.It was marked 634.5 mcg/ml baclofen and 3.4 mg/ml morphine.The hcp found out that there was no baclofen in the vile that was created; it was only morphine 50 mg/ml.On (b)(6) 2020 the patient went to the emergency room for overdose symptoms.The hcp was trying to refill the pump back to the correct drugs / concentration.It was being considered that 2.4 mg/day would be the lowest therapeutic rate for 50 mg/ml.The option to do a system contents removal was reviewed.The hcp indicated that they would be in contact with their company representative to get a catheter access port (cap) kit if they decide to do that or just leave the pump at a minimum rate.The new drug was noted as being baclofen with concentration 634.5 mg/ml at a dose rate of 141 mcg/day and morphine with concentration 3.4 mg/ml at a dose rate of.75 mg/day.Additional information was later received from a company representative on 2020-oct-27.The company representative was going to see the patient on (b)(6) 2020 to aid with performing a full system contents removal.No further patient complications have been reported as a result of this event.

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 the healthcare provider (hcp) via a manufacturer's representative (rep) on 2020-nov-09.It was confirmed that a system contents removal had been performed and new drug was put in the pump.The patient was discharged that evening after the new drug was put in and was doing well.It was confirmed that no devices would be returned as this issue was a drug error on the part of the company that provided the medication.It was confirmed that this company mislabeled the syringe with another patient who had the same first name.

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.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 friend/family member.The caller reported that the patient had gone in for a pump refill around (b)(6) 2020 and the pharmacy had made a mistake which they described as near fatal by placing the correct label of medication on the wrong vial of drug.The caller reported the patient was supposed to get a mixture of baclofen and morphine which is what the label said, however the actual drug in the vial was morphine.The caller reported the patient started to experience symptoms the day after which included acting really strange, hallucinated, nausea, lower gi symptoms, dizzy, confused, could not get out of bed, could not walk/walked ¿like frankenstein.¿ the caller reported after 36 hours with the wrong medication in the pump they called the healthcare provider (hcp).The caller reported the hcp had asked if the patient had narcan.The caller reported the patient was very hypersensitive to everything due to a previous spinal cord injury, so it takes about two days before the patient starts to feel normal after any pump change or adjustments.The caller reported this is what they thought was happening until the hallucinations started.The caller reported the patient was "oozing sweat like he just came out of the shower." the caller reported they got the patient to the pain center and the patient was put on oxygen.The caller reported they were monitoring the patient and they decided the patient was not in any distress.The caller reported they had brought in two hcps to work on the case who had told them they did not know what to do since they had never experienced this before.The caller reported the patient was taken to the withdrawal wing the next day.The caller reported they brought a nurse practitioner (np) from the pain center who was going to "evacuate" the pump and decrease the dose by 30%.The caller reported the np corrected the medication in the pump and was going to program the pump but was unable to since there was still the wrong medication in the catheter and tubing of the pump.The caller reported that the np then called the manufacturer and was told they would have to "evacuate" the pump.The np did not have a needle to access the cap.It took three days to correct the issue.The caller reported that from this experience the patient has had a lot of challenges since he was overdosing on morphine and having withdrawals from baclofen.The caller reported that after they corrected the error, the patient went into extreme morphine withdrawals.The caller confirmed everything was resolved at this time.

• 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: 10763488
• MDR Text Key: 213913027
• Report Number: 3004209178-2020-19017
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 53 YR