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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Pain (1994); Hot Flashes/Flushes (2153); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/15/2024
Event Type  Injury  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing dilaudid (hydromorphone) (10.0 mg/ml at 1.502 mg), clonidine (500.0 mcg/ml at 75.10 mcg), and bupivacaine (10.0 mg/ml at 1.502 mg) via an implantable pump for unknown indications for use.It was reported that on (b)(6) 2024, the nurse who comes to the home to refill pump noticed a volume discrepancy of expected volume in pump of drug.The expected volume return was 10 ml, and she withdrew 0.1 ml.At refill on (b)(6) 2024, the bridge bolus was programmed due to change of concentration.The patient came to the physician¿s office on (b)(6) 2024 reporting symptoms of "spacey, and weak".The physician stopped bridge bolus to lower daily infusion rate then next the physician removed drug from internal tubing and primed the catheter volume.There were no known environmental/external/patient factors that may have led or contributed to the issue.The patient medical history and weight were not available due to legal/confidential reasons.The patient status was alive and no injury.The issue was resolved.Additional information was from a healthcare provider (hcp) via a company representative (rep) listed the refill discrepancy.In (b)(6)2023 they expected reservoir volume was 10 ml but action volume was 7 ml.In (b)(6) 2023, they expected reservoir volume was 10 ml actual volume was 6 ml.In (b)(6) 2023, they expected reservoir volume was 10.8 ml actual volume was 5.5ml.On 2023-december-23, they expected reservoir volume was 10 ml actual volume was 2 ml.In (b)(6) 2024, they expected volume was 10 ml actual volume was 0 ml.On (b)(6) 2024, the patient representative stated that the patient was experiencing "severe flu like symptoms" "severe abdominal pain" "heat flashes.¿ additional information was from a healthcare provider (hcp) via a company representative (rep) stated that the patient was not having symptoms of overdose but rather underdose as approaching the refill date.An agent reviewed guidance for ¿overinfusion¿ and sent information from fca.The rep requested information on roller study, so an agent sent technical note.No additional information was given.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was reported that the company representative (rep) stated that the physician wanted to stop the bridge and do a complete system contents removal procedure.The rep stated that the physician has no one to assist in procedure so he wanted to be on the phone for the procedure.The technical services (tss) forwarded technical note for complete system contents removal.The rep was going to forward technical note on and if physician still wanted further assistance will call back.The patient became symptomatic with withdrawal symptoms.Additional information was from a healthcare provider (hcp) via a company representative (rep) wanted cancel bridge.The technical s ervices (tss) reviewed yes, all drugs will be cleared if he was doing the system contents removal procedure so bridge not necessary.Additional information was received from a company representative (rep) and healthcare provider (hcp) reporting that the event was not currently resolved.It was reported the hcp plans on replacing the pump and the date of replacement is currently not known.
 
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Additional information was received from a healthcare provider (hcp) and company representative (rep) reporting that the cause of the volume discrepancy was not determined.The cause of the patient's symptoms was also not determined.The rep reported that it was unknown if the patient had underdose symptoms.
 
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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 Key18975263
MDR Text Key338685458
Report Number3004209178-2024-07769
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630505
UDI-Public00643169630505
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2022
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2024
Date Device Manufactured01/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient SexMale
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