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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Insufficient Flow or Under Infusion (2182); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and a device manufacturer representative regarding a patient receiving bupivacaine (30 mg/ml at 7. 2 mg/day) and morphine (10 mg/ml at 2. 4 mg/day) via an implantable infusion pump. It was reported that the patient was getting alerts on his ptm while trying to deliver a bolus. He was at the office for a refill and per interrogation, 0ml should have been in the reservoir, but 5ml was aspirated. Codes 225 (safe state), 231 (pump reset), and 259 (pump memory error) were seen upon interrogation. The hcp was able to refill and update the pump successfully, however the pump continued to experience resets over the next 3 days. The pump reset and was reprogrammed 4 times. At the last reprogramming, the interrogation indicated that the estimated replacement interval was less than a month, despite the pump being implanted on (b)(6) 2021. They were able to program the pump to minimum rate using an 8840 programmer, then reprogram to the desired settings. The caller was advised to continue to monitor for alarms and alerts, and considerations were reviewed. The patient's weight was provided. No further complications were reported.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12012546
• MDR Text Key: 262474536
• Report Number: 3004209178-2021-09513
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/16/2021 Patient Sequence Number: 1