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

Model Number 8637-20

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144); Dizziness (2194); Therapeutic Response, Decreased (2271); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Lethargy (2560)

Event Date 03/01/2020

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 patient who was receiving 400 mcg/ml of baclofen at 69.35 mcg/day, 2600.0 mcg/ml of fentanyl at 350.8 mcg/day, and 15 mg/ml of bupivacaine at 2.601 mg/day via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome.On (b)(6) 2020, it was reported that the patient was having "some serious issues" and symptoms including high fever, which began in (b)(6), difficulty breathing/respiratory problems, muscle aching, vomiting and nausea lasting for about a month.The patient was quarantined for a week and took a covid-19 test on (b)(6) 2020.The test came back negative.On (b)(6) 2020, the patient also experienced dizziness, sluggishness, and anxiety.The patient felt that they were experiencing withdrawal symptoms with increased pain.According to the patient, the patient's pump had been making a single tone alarm since (b)(6) 2020.The patient initially noted that their pump refill date was (b)(6) 2020, but later stated that the refill date was (b)(6) 2020.However, because the patient had the fever beginning 2 weeks prior to the (b)(6) 2020 refill date, the patient's healthcare provider (hcp) opted not to fill the patient's pump.The patient was told their pump would be empty on (b)(6) 2020 and that a plan would be determined after this.The patient went to the er, where they had their covid-19 test, and had pump reservoir calculations performed.The hcp at the er told the patient that they had enough medication to last a longer period of time.The patient's main hcp, once it was confirmed that the patient did not have covid-19 and they did not have a steady fever (the patient noted that the fever comes and goes), scheduled the patient for a refill appointment on (b)(6) 2020.The patient was worried that they would not make it until monday as they had other health issues such as asthma and epilepsy and could not hear well.The patient noted that they were not aware that the pump was alarming the week of (b)(6) until "a day later" and worried that they would not hear a critical alarm.The patient requested clarification on the amount of medication in their pump reservoir since their main hcp and the er hcp provided the patient different information.The patient noted that their main hcp told them that the pump would "slow down." the patient provided information from the printout they received from their last refill on (b)(6) 2020.The patient noted that they had given themselves maybe 8 or 10 boluses since the refill.Based on the printout, the patient was allowed 3 boluses per day and "boluses says max daily dose 476.1 mcg dose 10mcg 17.6 res volume".It determined that if the patient had actually only given themselves a handful of boluses since (b)(6) 2020, that might allow the patient more time.The patient made a complaint against their main hcp, noting that they have put the patient in a "guessing game" twice, referencing this current event and an incident when the hcp wanted to reduce the patient's medication because it was thought that the patient didn't have insurance.The patient noted that they were considering removing their pump.No further complications were reported.Additional information was received from a consumer on 2020-jun-23 stating the pump was the cause of the patient's symptoms which were nausea, muscled spasms, and increased pain.It was noted that this was due to the pump that was not filled.There was conflicting info between the patient and the hcp's office, but it was noted the patient was suspected to have covid and was asked to quarantine, but by that time the hcp no longer had the medication and could not fill the pump so the patient had to stay 1 week in the hospital.After the week in the hospital on (b)(6) 2020 the alarm was resolved.The patient had since been able to schedule with the hcp and was scheduling regular decreases per another hcp's advice for gastro testing.It was noted that when it was completely decreased the patient was strongly considering no longer using the pump as they were not totally comfortable with the process.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10205786
• MDR Text Key: 196773333
• Report Number: 3004209178-2020-11199
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Date Device Manufactured: 09/06/2018
• 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): Hospitalization
• Patient Age: 41 YR