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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)

Patient Problems Arrhythmia (1721); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received by a consumer (con) and company representative (rep) regarding a patient who was receiving bupivacaine (5.0 mg/ml at 0.7091 mg/day) and dilaudid (hydromorphone) (6.0 mg/ml at 0.8510 mg/day) via implantable infusion pump.It was reported that for the past 2 years the patient has been experiencing over and under dosing from the pump.The patient stated that this occurs after refills and adjustments.The patient mentioned that at 11:50pm, 1am, and 2am they get mini doses from the pump causing symptoms like they cannot breathe.Of note, the patient never drops below 80% saturation.The patient also stated that sometimes the opposite happens, and the pump does not give them the medication and then medication all at the same time.The patient stated that it has not been confirmed that the pump is doing this, but the patient read about recalls online and believes the pump is doing this.The patient wants the healthcare provider (hcp) to look at the pump or take the pump out.The patient underwent an mri on (b)(6) 2021 to see if there was an inflammatory mass at the tip of the patient's catheter.Th mri did not end up scanning the location of the catheter tip so an inflammatory mass could not be determined.The pump did however stall at the time of the mri scan at 9:30am and recovered 30 minutes later.The remainder of the pump log did not show any abnormalities.The patient thought their pump alarmed on (b)(6) 2021; however, it was confirmed that the pump log did not show pump alarms occurring.The hcp decided to drop the patient's concentration of hydromorphone from 6 mg/ml to 0.8 mg/ml and brought the dose from 0.85 mg/day to 0.55 mg/day with plans to further decrease the dose to 0.45 mg/day.Additionally, the hcp disabled the patient's ptm dosing because the patient had reported that the pump systems were exacerbated after ptm use.The hcp provided the patient with oral hydromorphone for breakthrough pain.The patient's relevant medical history included 37 surgeries, been taken off blood pressure medication, and a crash cart was called a year ago february at a refill.The patient additionally mentioned feeling little surges of medication going through and that their heart races and blood pressure skyrockets.The patient also mentioned no longer getting a numbing feel ing since the bupivacaine has been removed but is getting an analgesic "nerve block" feeling from the chest down.

• 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: 12085018
• MDR Text Key: 265584556
• Report Number: 3004209178-2021-10110
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/29/2021
• Date Device Manufactured: 07/19/2017
• 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): Other