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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via manufacture representative regarding a patient receiving unknown drug via an implanted infusion pump. It was reported the patient's pump did not recover after waiting 2 hours after the mri. The caller stated the patient had since gone home and the office was closed. Tech services recommended having the patient follow-up with the physician on monday. It was noted the pump was at minimum rate mode. No symptoms were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via pump session reports. Review of the reports determined that the motor stall event no longer appeared in the logs because the pump had been updated multiple times. The logs, by design, have a 30 entry capacity so the motor stall entry had dropped off as would be expected. There was no issue with regards to the logs. No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via the pump logs. The pump logs dated (b)(6) 2020 showed a motor stall occurred on (b)(6) 2020 at 12:08 pm. The pump logs dated (b)(6) 2020 showed the pump motor stall recovery on (b)(6) 2020 at 3:26 am. The last entry showing on the logs was dated (b)(6) 2020 at 1:39 pm which was after the stall that occurred at 12:08 pm. The pump was delivering fentanyl (8,000 mcg/ml at 50 mcg/day), hydromorphone (6 mg/ml at 0. 0375 mg/day) and bupivacaine (15 mg/ml at 0. 094 mg/day) at the time of the event. 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10042762
• MDR Text Key: 190541092
• Report Number: 3004209178-2020-08364
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial