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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Fatigue (1849); Overdose (1988); Pain (1994); Vomiting (2144); Complaint, Ill-Defined (2331); Loss of consciousness (2418)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 30-nov-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving fentanyl (2000 mcg/ml at 988 mcg/day), bupivacaine (5 mg/ml at 2.4699 mg/day), and baclofen (800 mcg/ml at 395.18 mcg/day) via an implantable infusion pump.It was noted that the patient was on baclofen because his legs were kind of "screwy".The indication for use was non-malignant pain.It was reported that the patient thought the pump was doing something wrong.The caller stated that it seemed like it was working after being implanted but that he felt like they needed to increase the medication but not by much.It was noted that after the pump was installed a dye study was attempted but they could not get the mediation out of the catheter so it was aborted.It was reported that the healthcare provider (hcp) was not concerned and continued to increase the patient's medication.The caller stated that the medication were starting to get to the point where they were "dialed in".The first pump refill was on (b)(6) 2018, the pump was increased by 4.5 percent and the personal therapy manager (ptm) bolus was changed from every 2 hours to every hour.Within 24 hours after they performed the refill the patient ended up in the emergency room (er) two times (on (b)(6) 2018).The reason behind the er visits was due to the patient passing out because of a sudden overdose; the patient felling like he was getting too much medication and that when they filled the pump whatever was causing the dye study to be aborted fixed itself and he began getting the full dose of medication.It was noted that the patient was getting drowsy, was out of it, throwing up, had a hard time catching his breath and could not poop.It was noted that the patient was also on oral medications because he had problems with his neck but that he was stripped down from "taking 4¿now none at all".The caller stated that the medication is either building up in his system because at 15:00, 17:00, and 23:00 he gets the feeling of being over medicated.It was stated that on friday they turned off the patient's ptm because the healthcare provider (hcp) thought it was being used too much and causing the problem.The caller reported that yesterday the pump was decreased by 10 percent and that he had a lot more pain and then around 15:00 or 16:00 he felt like he was getting too much medication and then the pain went away.A device manufacturer representative came to the hcp office yesterday and did not find any issues with the infusion system.The caller stated that he is going to the hcp tomorrow for a refill appointment because they think he got a bad batch of medication and that the catheter was being replaced on (b)(6) 2018.No further complications have been reported as a result of this event.

• 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: 7893735
• MDR Text Key: 120861647
• Report Number: 3004209178-2018-21094
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2018

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: 08/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 09/20/2018
• Date Device Manufactured: 03/05/2018
• 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
• Patient Age: 49 YR