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

Model Number 8637-40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Complaint, Ill-Defined (2331)

Event Date 06/01/2017

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was receiving fentanyl at an unknown concentration and dose via an implantable pump for spinal pain.It was reported on (b)(6) 2017 that the patient¿s pump was refilled with the wrong medication.It was detailed that the patient was supposed to have only fentanyl put in the pump but they put in fentanyl and clonidine as the clinic grabbed the wrong patient¿s medication and put it in the pump.It was noted that the medication mistake made the patient ¿goofy¿ and the patient feel three times in five days.It was indicated that the dose and concentration were unknown, and that the patient was only supposed to have fentanyl in the pump but at one time clonidine was accidentally put in.The date of the event was (b)(6) 2017.Physician listings were requested.No further complications were reported or anticipated.

• 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: 6822717
• MDR Text Key: 83747865
• Report Number: 3004209178-2017-18194
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Other
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2017
• Date Device Manufactured: 03/12/2014
• 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 Age: 68 YR