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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problems Fever (1858); Nausea (1970); Malaise (2359); Coma (2417)

Event Date 06/30/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731, serial # (b)(4), implanted: (b)(6) 2006, product type: catheter.Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 09-feb-2008, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient receiving baclofen and bupivacaine at unknown concentrations and doses via an implantable infusion pump.The indication for use was intractable spasticity due to spinal cord injury.It was reported that the patient presented to the emergency room (er) with a fever and nausea.The patient reported that at his last refill the doctor noticed a discrepancy between what was left in the pump and what the programmer read, so when the patient began to feel ill he decided to go to the er.The pump was read to check for alarms and stalls, and none were seen.A dye study was attempted but the catheter could not be aspirated, so the dye study was aborted.The issue was not considered resolved.There were no environmental, external or patient factors which may have led or contributed to the issue.The patient's status at the time of the report was alive - no injury.The patient's weight was unknown.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 8731, (b)(4), implanted: (b)(6) 2006, product type : catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a device manufacturer representative on 2018-jul-03.It was reported that the volumes at the reported discrepancy event were: erv=4ml, arv=0ml.The cause of the volume discrepancy was not determined.The cause of the inability to aspirate the catheter was not determined.The catheter was replaced on (b)(6) 2018.No further complications were reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).The failure of the baclofen pump resulted in a "massive dose of baclofen", which resulted in a coma.The patient recovered from the coma and was transferred to an acute rehabilitation.No further issues were reported or anticipated.

• 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: 7658686
• MDR Text Key: 113257146
• Report Number: 3004209178-2018-14886
• Device Sequence Number: 1
• Product Code: LKK
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2018
• Date Device Manufactured: 09/22/2011
• 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; Other; Required Intervention
• Patient Age: 61 YR