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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problem Underdose (2542)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8784, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 15-jun-2018, udi#:(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving dilaudid (10 mg/ml at 1 mg/day) via an implantable infusion pump.The indication for use was noted to be spinal pain.It was reported that the patient came into the hcp's office on (b)(6) 2018 with symptoms of underdose.The doctor "thought not full occlusion." a catheter access port study was done and the doctor was unable to aspirate.The patient was taken to the operating room the same day, where an occlusion was found "in first 1 foot of catheter." a 12 inch segment of the proximal pump section was replaced.There were no environmental, external or patient factors which may have led or contributed to the issue.The issue was considered resolved.The patient's status at the time of the report was alive - no injury.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable intrathecal catheter (b)(4) found several kinks in the catheter body and damage to the transition tube.(b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 7574242
• MDR Text Key: 110262022
• Report Number: 3004209178-2018-12750
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,Followup
• Report Date: 08/20/2018

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: 02/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR