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)

Event Date 02/12/2022

Event Type  Injury  

Event Description

Information was received from a friend/family member regarding a patient who was receiving dilaudid (hydromorphone) (concentration and dose unknown) via an implantable pump for spinal pain.It was reported that a week ago, the patient "started feeling funny".It was noted "not last night but the night before, she felt like it started pushing drugs into her".The patient got a sharp pain in their belly and it felt like someone was "iv piercing" their stomach.The patient became loopy from the drugs and started having seizures.The patient was taken byambulance to the emergency room (er) but sent home.It was further reported they took the patient to another hospital where their blood pressure (bp) was 88/64 and the patient was having seizures in the waiting room, and the hospital staff told caller they could not help them and sent them to another hospital.They went to another hospital where the patient had two seizures in the waiting room, then would not allow the caller back with the patient due to covid.The patient reported they were rude, ignored them, and "didn't care if she lived or died".The patient continued to complain of sharp pain in the belly at the pump area and was not sure if it was the drugs going to their head or if it was truly painful.  the caller was asking for help finding someone to check the patent's pump as the patient "almost died twice of overdose" and they could not find anyone to help.They called the patient's healthcare provider (hcp) who told the caller "she would be dead by the time you got here".

Manufacturer Narrative

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

• 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: 13770231
• MDR Text Key: 287260314
• Report Number: 3004209178-2022-03299
• 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
• Reporter Occupation: Non-Healthcare Professional
• Report Date: 03/15/2022

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2022
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial