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

Model Number 8637-40

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dyspnea (1816); Unspecified Infection (1930); Overdose (1988); Reaction (2414); Decreased Respiratory Rate (2485)

Event Date 11/09/2018

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 consumer and a healthcare professional (hcp) via a manufacturer representative regarding a patient receiving morphine programmed to minimum rate (concentration unknown) via an implantable pump for spinal pain.It was reported the patient was having difficulty breathing and was being overdosed.It was stated that the patient believed they were getting overdosed despite the pump being at minimum rate.The patient stated the difficulty breathing was related to the pain pump/therapy.It was noted that the cause of the difficulty breathing was from the medication (morphine).The patient stated they were morphine tolerant and the way the medication was released suppressed their breathing to a point where they needed narcan.The patient stated they were being monitored on a day to day basis.It was noted the patient was still having residual side effects and was on antibiotics.The patient stated they were not a doctor, but stated that they were close to bilateral pneumonia and the patient stated for someone who has had it before they know.The patient did not provide their weight when asked.The patient experienced the difficulty breathing the day after implant ((b)(6) 2018).The patient inquired if their first pump was on recall.The patient would like the pump turned off.It was noted as a sudden change in therapy/symptoms.The pump authorization form was emailed to the rep at the hcp's request.The event date for the over dose was (b)(6) 2018 and the event date for the difficulty breathing was (b)(6) 2018.Additional information received from a manufacturer representative (rep) stated the patient reported the pump was overdosing them and was at minimum rate.The patient was advised to go to the emergency room.The patient requested for the pump to be turned off.The hcp completed the pump off form and it was faxed back.The rep was on the way to the hospital to turn the pump off when the rep received a phone called from the patient that the hcp at the hospital recommended the pump not be turned off.The patient stated they now do not want the pump to be shut off.No environmental factors may have led or contributed to the issue.It was unknown if the issue was resolved.The patient's weight was asked, but unknown.The patient's medical history was asked, but unknown.The patient's status was alive-no injury, no further complications were reported/anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8153874
• MDR Text Key: 130027602
• Report Number: 3004209178-2018-27434
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2018
• Date Device Manufactured: 10/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR