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

Model Number 8637-20

Device Problems Failure To Service (1563); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# unknown, product type: programmer, physician.Information references the main component of the system.Other relevant device(s) are: product id: 8840, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient receiving morphine (10 mg/ml at 1.395 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2018 it was reported that the empty pump alarm was occurring.The patient had missed their pump refill visit because they were not able to get transportation.The patient experienced withdrawal which had come on suddenly.Per the hcp, the patient did not want the pump anymore and they had been in the process of weaning the patient off the medication and eventually removing the pump.Because of this, they wanted to stop the alarm and discontinue the use of the pump now.The option of turning the pump off was reviewed.The hcp chose to program the pump to minimum rate mode and program a full reservoir volume.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id 8840, serial# (b)(4), product type: programmer, physician.The main component of the system, other relevant device(s) are: product id: 8840, serial/lot# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 25-jun-2018 and 26-jun-2018 from the healthcare professional (hcp) who reported that at the visit on (b)(6) 2018, the pump reservoir was filled with saline and then programmed to run at minimum rate.The patient had since come back to the office and bupivacaine was put in the pump.The patient was doing well, and everything had been fine since adding the bupivacaine.No further complications were reported/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: 7586081
• MDR Text Key: 110578127
• Report Number: 3004209178-2018-13036
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Date Device Manufactured: 06/18/2014
• 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: 39 YR
• Patient Weight: 90