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 Muscular Rigidity (1968)

Event Date 03/26/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: product id: 8578, serial/lot (b)(4), ubd: 18-feb-2017, (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving ba clofen (2000 mcg/ml at 884 mcg/day) via intrathecal drug delivery pump.The indication for use was noted as intractable spasticity and cerebral palsy.It was reported that the patient had increased spasticity/tone "over the past year" (from (b)(6) 2018).They had tried to do dye studies two times in the (b)(6) 2017 time frame but were unable to aspirate both times.A catheter revision was completed on (b)(6) 2018; they did not take out the whole catheter but replaced the connector.When the surgeon disconnected from the pump he noted "scarring or some sort of debris" that may have partially occluded the catheter.The surgeon removed the debris and got good flow of cerebrospinal fluid (csf) he also did a dye study in the operating room to confirm patency.There were no further complications reported at this time.

Manufacturer Narrative

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: 7378661
• MDR Text Key: 103731079
• Report Number: 3004209178-2018-05935
• 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,Followup
• Report Date: 04/05/2018

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: 10/28/2016
• 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: 03/26/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 04/05/2018
• Date Device Manufactured: 05/04/2015
• 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: 20 YR