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

Model Number 8637-20

Device Problem Protective Measures Problem (3015)

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

Event Date 06/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen with an unknown concentration and an unknown daily dose via an implantable pump for an unknown indication for use.It was reported that a critical alarm occurred in a synchromed ii pump on (b)(6) 2019 at 21:00 in the evening.On (b)(4) 2019, the pump was interrogated and the event logs were checked.The hcp noticed that the logs showed that the pumps turned automatically in minimum rate flow (code error 07) and was in safe state.An image of the clinician programmer was provided an confirmed the safe state event.It was reported that no apparent cause was identified as possible source of the pump reset and there were no reported environmental/external/patient factors that may have led or contributed to the issue.Then the pump was interrogation and the rate was reprogrammed with the old settings and the pump started working as intended.Patient is fine and this event didn¿t cause any symptoms.The issue was resolved at the time of this report.The patient status was alive - no injury.There were no reported complications.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the concentration of baclofen being used in the pump was 2000 mcg/ml with a daily dose of 490 mcg/day.It was reported that there was a refill on (b)(6) 2019, but there were no concentration or daily dose changes that occurred.There were no reported complications.

• 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: 8735152
• MDR Text Key: 149231043
• Report Number: 3004209178-2019-12389
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• 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: 07/01/2019
• Date Device Manufactured: 08/10/2016
• 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