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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503)

Patient Problems Pain (1994); Loss of consciousness (2418); Decreased Respiratory Rate (2485); Lethargy (2560)

Event Date 03/17/2024

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 receiving dilaudid (hydromorphone) (unk mg/ml at unk mg/day) via an implantable pump for unknown indications for use.It was reported that a pharmacist stated that the patient was hospitalized on (b)(6) 2024 with overdose symptom.The company representative (rep) was notified and assisted the hospitalist decreasing the dose to the lowest dose and the patient improved but now the patient was having increased pain due to the decrease in dose.Additional information was from a healthcare provider (hcp) via a company representative stated that the patient came to the hospital today with symptoms of respiratory depression and lethargy.The patient was barely responsive, and in the hospitals estimation the symptoms appear to be consistent with excessive medication.The hospital applied a magnet to the pump over the skin.Upon reading the pump it was determined that the pump motor has stalled since 10:47 pm this evening (after magnet was applied).The hospital ordered to set the pump to minimum rate in case the motor restarts later this evening.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 not resolved.

Manufacturer Narrative

B5 corrected.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 receiving dilaudid (hydromorphone) (unk mg/ml at unk mg/day) via an implantable pump for unknown indications for use.It was reported that the patient came to the hospital today with symptoms of respiratory depression and lethargy.The patient was barely responsive, and in the hospitals estimation the symptoms appear to be consistent with excessive medication.The hospital applied a magnet to the pump over the skin.Upon reading the pump it was determined that the pump motor has stalled since 10:47 pm this evening (after magnet was applied).The hospital ordered to set the pump to minimum rate in case the motor restarts later this evening.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 not resolved.Additional information was received from the manufacturer representative (rep).The rep called in to update that the patient had symptoms of overdose, breathing, respiratory, unresponsive.The hcp applied a magnet and the pump went into motor stall.The rep stated he set the pump to minimal rate.The rep saw the patient today, and they were a little more awake, lethargy, and was on a narcan drip.The hospital was in the process of reducing the drip and see how the patient responded.Additional information was received from a healthcare provider (hcp).It was reported that a pharmacist stated that the patient was hospitalized on (b)(6) 2024 with overdose symptom.The company representative (rep) was notified and assisted the hospitalist decreasing the dose to the lowest dose and the patient improved but now the patient was having increased pain due to the decrease in dose.Additional information was received from the manufacturer representative.It was reported that the national answering service called the rep into the hospital, and the staff at the hospital reported the event.The rep did not know the cause of the hospitalization and overdose.The pump was set to minimum rate to resolve the hospitalization and overdose.The hospitalization and overdose was resolved and the patient will see their pain management doctor for pump adjustment.The cause of the pump motor stall was the magnet that was applied, and the pump seems to have recovered from the stall on its own.

• 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: 18976575
• MDR Text Key: 338549358
• Report Number: 3004209178-2024-07789
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000634094
• UDI-Public: 00763000634094
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 06/17/2022
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female