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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Inappropriate or Unexpected Reset (2959); Appropriate Term/Code Not Available (3191); Data Problem (3196)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: a810, product type: software.The pump was implanted in 2019.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 manufacturer's representative regarding a patient who was receiving morphine (30.0 mg/ml at 5.995 mg/day), bupivacaine (10.0 mg/ml at 1.998 mg/day), and clonidine (50.0 mcg/ml at 9.992 mcg/day) via an implantable infusion pump for chronic benign pain.It was reported the patient was brought to the emergency room on (b)(6) 2021 due to withdrawal symptoms/increased pain level.The patient's spouse thought they may have heard an alarm once or twice the day before, but did not immediately think of the pump.They did not hear an alarm after that, and also not at night.It was also indicated the patient was hard of hearing and wore a hearing aid during the day.The logs were checked on (b)(6) 2021 when the patient was brought in.Event codes 07 (critical alarm - safe state), 2c (critical alarm - pump reset firmware error), and 01 (critical alarm - pump reset) had occurred on (b)(6) 2021 at 12:56.An attempt was made to reprogram to simple continuous mode via the tablet, but it was not possible.The tablet gave the message "update cannot start, invalid provisional data" and displayed service codes 101 (pump reset occurred) and 87 (pump in safe mode).Reprogramming was successful using an n'vision programmer.Upon double checking with the tablet, codes 1a (motor stall recovery), 07 (critical alarm - safe state), and 18 (event status cleared) were observed in the logs.The pump function seemed to be restored.An extra single bolus of 0.500 mg was given.The patient was hospitalized for one night, where they and the pump were monitored.No events were discovered in the logs the day after and the patient was discharged.The issue was resolved and the patient status was alive - no injury.Surgical intervention did not occur nor was planned.The only reported contributing factor was the patient was on holiday and had stayed in a camper.The last refill/hospital visit took place in (b)(6) 2021.Further complications were not reported.Images of the clinician tablet were provided, indicating the pump was in safe state and a pump reset had occurred.A pump session report was provided.The "safe rate in use," "reset occurred - watchdog [firmware error]," and "reset" events occurred on (b)(6) 2021 at 12:56.The "safe rate in use," "motor stall recovery occurred," and "event status cleared" events occurred on (b)(6) 2021 at 18:30; these events occurred at the same time the pump was updated.

• 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: 12108804
• MDR Text Key: 259720903
• Report Number: 3004209178-2021-10337
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• 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: 06/21/2021
• Date Device Manufactured: 10/30/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 64 YR