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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503); Intermittent Infusion (2341); Mechanical Jam (2983)

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

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received from a healthcare provider regarding a patient receiving baclofen 2000mcg/ml at 1291.1mcg/day and bupivacaine 3.4mg/ml at 2.1949mg/day via an implantable pump.The indication for use was intractable spasticity.The healthcare provider reported a motor stall was seen at initial interrogation.The patient had an mri on (b)(6) 2017 and the pump was not checked post mri.The event logs showed (b)(6) 2017 motor stall occurred and (b)(6) "2107" stopped pump period may exceed tube set.The mri was not done due to a suspected problem with the device or therapy.The motor stall recovery has not occurred.It was reviewed to re-interrogate the pump with logs every 10-15 minutes until they see a recovery.There were no patient symptoms and no further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received reported that the actions and interventions taken to resolve the motor stall and tube set message was to re-interrogate the pump.The motor stall did recover on (b)(6) 2107 at 11:35.Per the logs a motor stall also occurred on (b)(6) 2107 at 8:29 and a recovery occurred on (b)(6) 2017 at 9:36.No further patient complications were reported.

Manufacturer Narrative

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

Event Description

Corrected information: the stopped pump period may exceed tube set message occurred on (b)(6) 2017.

• 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: 6812796
• MDR Text Key: 83683780
• Report Number: 3004209178-2017-17930
• 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: health professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Date Device Manufactured: 12/11/2014
• 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-0592-2009
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 86