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

Model Number 8637-20

Device Problem Pumping Stopped (1503)

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

Event Date 03/20/2022

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 foreign healthcare provider (hcp) via a distributor's representative (dist. ) regarding a patient who was receiving 4 mg/ml of morphine at 1. 9476 mg/day and 6 mg/ml of bupivacaine at 2. 9215 mg/day via an implantable pump. On (b)(6) 2022, it was reported that a service error 100 (indicative of a motor stall) was detected during a pump service appointment. The hcp had stopped the pump for 24 hours, but when they attempted to restart the pump, the error code appeared. No external factors that might have caused or contributed to the issue. The logs provided showed an error code of 232 (also indicative of a motor stall), but no other issues were noted. Surgical intervention was scheduled for (b)(6) 2022. The issue was not considered resolved at the time of the report. The patient's status was listed as "alive - no injury". Additional information was received from a foreign hcp via a manufacturer representative and a distributor representative. The distributor representative went to the hospital on (b)(6) 2022 to check the pump. After synchronizing, they found no error message. They saw that the pump had restarted on (b)(6) 2022 at 12:26 pm. It was indicated the patient was well and had follow-up, and no health issues were found. It was decided to not change the pump and to keep the patient under medical supervision. A session report from (b)(6) 2022 was provided, indicating the pump was in a state of motor stall. A session report from (b)(6) 2022 was provided, indicating a motor stall recovery occurred on (b)(6) 2022 at 12:26 pm. Additional information was received. It was reported the pump stalled again on (b)(6) 2022 around 2:30 am. It was decided to replace the pump the week of (b)(6) 2022. The pump would be returned after replacement. Regarding the pump being stopped for 24 hours, this was a deliberate decision by the hcp.

• 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: 13929843
• Report Number: 3004209178-2022-03853
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: Female
• Patient Weight: KG
• Patient Outcome(s): Required Intervention