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

Model Number 8637-20

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bradycardia (1751); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Overdose (1988); Tachycardia (2095); Anxiety (2328); Complaint, Ill-Defined (2331); Coma (2417); Alteration In Body Temperature (2682)

Event Date 04/02/2018

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 regarding a patient who was receiving dilaudid at an unknown concentration and dosage via an implantable infusion pump for failed back surgery syndrome and spinal pain. It was reported that the patient was overdosed during a refill procedure. The healthcare provider (hcp) took the patient to a side room and did not use ultrasound or fluoroscopy beforehand to verify the port location the way it was normally performed. The hcp stuck her and the patient said it did not feel right and the hcp said that she hit the side of it. There was a sudden change in therapy/symptoms. The hcp left the room and the patient suddenly was not feeling right, became really hot, her heart started racing, she could not breathe, and she had a rush feeling in her head that would not go away. The patient told one of the nurses that walked by and the nurse questioned the patient about the medications the patient took earlier in the day. The patient took the other medications early in the morning, and it was 1:30pm. The nurse took the patient's blood pressure and said that it was falling and the patient's heart rate was falling as well. The nurse who performed the refill went to get the ultrasound and the patient was taken to the procedure room. The patient was told that the hcp performed rescue breathing, was given narcan and additional medication to dilute the medication that was around the pump. The patient was sent to the emergency room (er) and was given more narcan and received a narcan drip, which she believed was alternated. The patient was sent to the intensive care unit (icu), and the patient woke up after two days. The patient was discharged the afternoon after she woke up. The patient said she was told that only three months worth of medication was filled in the pump and the other three months worth did not make it in the pump. The patient said that she typically was refilled every six months, but would need to come back in three months and she was really scared to have a refill. The patient had a follow up with her hcp on (b)(6) 2018. Since the incident, the patient had been experiencing high blood pressure, which she never had before. The situation was resolved at the time of the report. No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7440258
• MDR Text Key: 105820735
• Report Number: 3004209178-2018-08305
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/22/2013
• 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-1060-2011

Patient Treatment Data

Date Received: 04/18/2018 Patient Sequence Number: 1