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

Model Number 863740

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dyspnea (1816); Nausea (1970); Sneezing (2251); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 morphine at 30 mg/day via an implanted pump.On (b)(6) 2020 the patient reported that once before maybe 10 years ago or longer he had gone to the er (emergency room) because he had gone in for a refill and they put something in the pump and by the next day he was sick and sneezing and sick to his stomach.After another day or so, he was sicker and could hardly breath.He was then in a navy hospital 3 days trying to get better.It was a whole week.He was sent for tests, maybe an mri, and they showed the pump was working fine.He was also on oral medications.They found out what was put in the pump was not supposed to be in there.Per the patient, he was never told if the medication or dosage/concentration was incorrect.He stated that he seemed to be going through withdrawal.Nine hours after they refilled it, he was much better.No further complications were reported/anticipated.

• 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: 9897239
• MDR Text Key: 185613351
• Report Number: 3004209178-2020-06354
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2020

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: 07/14/2008
• Device Model Number: 863740
• Device Catalogue Number: 863740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 03/30/2020
• Date Device Manufactured: 01/20/2007
• 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): Hospitalization