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

Model Number 8637-40

Device Problems Application Program Problem (2880); Aspiration Issue (2883)

Patient Problem Muscular Rigidity (1968)

Event Type  Injury  

Manufacturer Narrative

Refers to the main device, other components include: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2008, product type catheter.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving baclofen at an unknown concentration and dosage and morphine at an unknown concentration and dosage via an implantable pump for intractable spasticity.On (b)(6) 2017, it was reported it was reported that the patient's catheter could not be aspirated and the pump rotors did not appear to rotate during a rotor study.It was noted that a motor stall was not reported or confirmed through the pump logs.The patient also reported increased spasticity.It was confirmed that a dye study and a rotor study had been performed.It was planned that the system would be replaced.It was unknown what, if any, environmental/external/patient factors that may have led or contributed to the issue.The cause of the inability to aspirate the catheter and the pump rotors not rotating was not determined.It was noted that the hcp may know more, specifically about the catheter, when the system is replaced.The rep noted that they would collect the pump and catheter at the replacement to send back to medtronic for analysis.The issue was not considered resolved at the time of the report.The patient's status was listed as "alive-no injury".No further complications were reported.

• 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: 7038361
• MDR Text Key: 92300937
• Report Number: 3004209178-2017-23895
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 11/16/2017
• Date Device Manufactured: 07/31/2014
• 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