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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Respiratory Distress (2045); Sepsis (2067); Fluid Discharge (2686)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8590-9, lot #: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: accessory.Product id: 8709sc, lot #: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter.Product id: 8709sc, lot #: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8590-9, serial/lot #: (b)(4), ubd: 28-feb-2014.Product id: 8709sc, serial/lot #: (b)(4), ubd: 17-apr-2014, udi#: (b)(4).Product id: 8709sc, serial/lot #: (b)(4), ubd: 13-apr-2014, 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 (hcp) via a device manufacturer representative regarding a patient receiving baclofen (4000 much/ml at 24 mcg/day) via an implantable infusion pump.The patient had a history of multiple sclerosis.It was reported that the patient presented to the hospital with respiratory distress and sepsis, the pump replacement incision site was draining yellow/green fluid.The decision was made to admit the patient over the weekend for lab work, antibiotics and monitoring.The system later explanted on (b)(6) 2018.It was reported that the patient living in a nursing home may have led or contributed to the issue.The explanted devices were disposed of and would not be made available for analysis.The issue was reported to be unresolved at the time of report.The patient was alive with no injury.No further complications have been reported as a result of this event.Issues maintaining or delivering therapy.No problem detected.Adverse event without identified device or use problem.Device not returned.Respiratory distress, sepsis, fluid discharge.No findings available.Unanticipated surgical intervention.Other known clinical side effects and therapy effects.Life threatening event\unknown.No identified product issue.

Manufacturer Narrative

Concomitant medical products: product id: 8590-9, lot# n323676, implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: accessory.Product id: 8709sc, lot# h819946501, implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter.Product id: 8709sc, lot# h819412305, 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 device manufacturer representative regarding a patient receiving baclofen (4000 much/ml at 24 mcg/day) via an implantable infusion pump.The patient had a history of multiple sclerosis.It was reported that the patient presented to the hospital with respiratory distress and sepsis, the pump replacement incision site was draining yellow/green fluid.The decision was made to admit the patient over the weekend for lab work, antibiotics and monitoring.The system later explanted on (b)(6) 2018.It was reported that the patient was living in a nursing home may have led or contributed to the issue.The explanted devices were disposed of and would not be made available for analysis.The issue was reported to be unresolved at the time of report.The patient was alive with no injury.No further complications have been reported as a result of this event.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8116903
• MDR Text Key: 128799416
• Report Number: 3004209178-2018-26528
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: 01/28/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2013
• 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: 11/28/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/28/2019
• Date Device Manufactured: 03/26/2012
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR