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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)

Patient Problem Underdose (2542)

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: (b)(6) 2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving dilaudid 20mg/ml at 1mg/day and bupivacaine 10mg/ml at 0.5mg/day via an implantable pump.The indication for use was non-malignant pain.It was reported that the patient felt he was not receiving drug via his pump.It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue.The diagnostics and troubleshooting performed was a catheter dye study was attempted, however the catheter was felt to be occluded.The patient was referred to the neurosurgeon for a catheter revision where the patient was scheduled for elective removal and replacement of the intrathecal catheter.The catheter was replaced.The issue was resolved at the time of the report and it was noted that the healthcare provider would have no further information regarding the event.The patient status was noted as alive, no injury and no further complications were reported or 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: 7633249
• MDR Text Key: 112139748
• Report Number: 3004209178-2018-14179
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• 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: 06/21/2018
• Date Device Manufactured: 03/17/2018
• 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