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

Model Number 8637-20

Device Problems Use of Incorrect Control/Treatment Settings (1126); Output Problem (3005); Data Problem (3196)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was provided by a healthcare provider (hcp) via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver morphine [5 mg/ml] at 0.6595 mg/day, indicated for spinal pain.The patient presented at a refill appointment on (b)(6) 2018, reporting that he was ¿feeling like crap.¿ it was unknown if this was considered a sudden or gradual change in therapy/symptoms.The event date occurred in 2018; it was unknown when the patient¿s symptoms started between the last refill on (b)(6) 2018, to when he presented with them at the refill appointment on (b)(6) 2018.The hcp read the pump initially, and then the nurse read the pump.It was stated that the dose switched from 0.6595 mg/day to 0.0318 mg/day (minimum rate).The caller stated that she had the last three session data reports to send in, and then noted the report from the most recent refill does show the pump set at minimum rate, which they hadn¿t noticed before.Three session data reports were provided from when the pump was examined on (b)(6) 2018.It was stated that on the (b)(6) 2018 printout, upon interrogation the current pump settings indicated minimum rate; however, looking at the printout before from (b)(6) 2018, when the pump was updated the pump status after the update read "simple continuous." it was reviewed that there is another session data report for (b)(6) 2018; when looking at the "current pump settings" it shows that the pump was examined at 12:13, but that it was last updated the minute before, at 12:12.(at the time of the report, it was unknown what the pump was set at when it was initially read at the update at 12:12.)the caller was encouraged to have the hcp read the logs to get further information and it was suggested that the hcp call technical services directly for further assistance.The caller was to follow-up with the hcp.Additional information was received from a hcp on 2018-jun-29.It was clarified that the pump being set to minimum rate was different than expected.The hcp did not program the pump to minimum rate.The cause of the pump being set to minimum rate had not been determined.It was clarified that the patient "feeling like crap" occurred prior to the refill on (b)(6) 2018, sometime between the may adjustment and the june refill.As an action/intervention taken to resolve the issue, they reprogrammed the pump back to 659.6 mcg daily.They brought the patient back in the next day to confirm the settings were the same, then again the following week.It was indicated that the patient's symptoms and the pump being unexpectedly programmed to minimum rate had been resolved.No further complications were reported or anticipated.

Manufacturer Narrative

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

• 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: 7680189
• MDR Text Key: 114412891
• Report Number: 3004209178-2018-15559
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• 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: 08/08/2018
• Date Device Manufactured: 07/08/2016
• 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: 57 YR
• Patient Weight: 91