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

Model Number 8637-40

Device Problems Pumping Stopped (1503); Application Program Problem (2880); Protective Measures Problem (3015)

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

Event Date 06/01/2018

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 regarding a patient who was receiving 10 mg/ml morphine at 0.500 mg/day via an implantable pump for failed back surgery syndrome and spinal pain.It was reported that the patient's pump had been alarming since (b)(6) 2018 every hour.They went to the doctor on (b)(6) 2018 and it was not alarming.The doctor interrogated the pump and did not see any alarms.The patient was not due to be filled until (b)(6) 2018 and the pump alarm date was (b)(6) 2018.It was noted the battery had 24 months left.The reservoir had 16.5 ml and the low reservoir alarm was set for 2.0 ml.The healthcare professional (hcp) said if the pump alarmed again to record the alarm.Then, on (b)(6) 2018, the pump began to alarm again every 10 minutes.No symptoms were reported.No further issues were reported or anticipated.Additional information was received from a healthcare professional (hcp) via a manufacturer's representative (rep).It was reported that the cause of the pump alarm was determined to be a motor stall.No actions/interventions had been taken to resolve the pump alarm.The pump alarm had not been resolved.

Manufacturer Narrative

Fdc 92 no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a manufacturer representative (rep).The pump was found to be in a motor stall on 2018 (b)(6).The pump was read at the pain clinic on 2018 (b)(6) and logs indicated stall and safe state.The patient was put on oral medication and the issue was not resolved.A pump replacement was planned for 2018 (b)(6).The patient's status was noted to be "alive - no injury".Further information was received indicating multiple motor stalls and recoveries occurred beginning on 2018 (b)(6).No further issues 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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7609298
• MDR Text Key: 111337145
• Report Number: 3004209178-2018-13603
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/07/2013
• 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): Required Intervention
• Patient Age: 62 YR