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

Model Number 8637-20

Device Problem Mechanical Jam (2983)

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

Event Date 08/22/2017

Event Type  malfunction  

Event Description

Information was received from a healthcare professional regarding a patient receiving unknown baclofen 2000mcg/ml for a total dose of 103.4mcg/day via an implantable pump for intractable spasticity.It was reported a motor stall was seen at initial interrogation, and the patient recently had an magnetic resonance imaging (mri).The logs were read and a motor stall recovery had not occurred.It had not been less than 2 hours since the patient exited the mri field.Telemetry state was reviewed, and was discussed re-interrogating the pump with longs.It was noted that the patient was sent to the emergency room since they did not have a motor stall recovery message in the logs.It was advised to check the pump logs again using a clinician programmer and recheck until a motor stall recovery was noted in the logs.No symptoms were reported.Event date was noted as (b)(6) 2017.No further complications were reported/anticipated.

• 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: 6817751
• MDR Text Key: 83656562
• Report Number: 3004209178-2017-18067
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 08/24/2017
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z#Z-0591-2009
• Patient Sequence Number: 1
• Patient Age: 48 YR