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

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2017, product type: catheter.The main component of the system; other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 03-feb-2019, 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 3 mg/ml at 1.5 mg/day via an implantable pump.The indication for use were was non-malignant pain.It was reported that the patient had volume discrepancies at the last 3 refills.The healthcare provider stated the patient was only getting about 40% of expected volume and was concerned that there was an issue with the catheter.There were no noted environmental, external or patient factors that may have led or contributed to the issue.A dye study was performed on (b)(6) 2018.The healthcare provider had difficulty aspirating the catheter but was able to clear the catheter volume.The dye was injected and the physician stated felt more resistance injecting dye than normal.The physician was able to inject dye and dye flowed through the catheter and was seen in/at the catheter tip level.There were no obvious kinks or tears in the catheter.The healthcare provider planned to do a catheter revision at a future date.The issue was not resolved at the time of the event.The patient status was noted as alive, no injury and no further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that the cause of the volume discrepancies and resistance felt while injecting dye during the dye study was not determined.No kink was observed at the replacement.No further complications were reported.

Manufacturer Narrative

Product id 8780 (b)(4) implanted: (b)(6)2017 explanted: (b)(6)2018 product type catheter.(b)(4)if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative on (b)(6)2018.It was indicated that the pump was delivering dilaudid [3 mg/ml] at 0.4994 mg/day.It was reported that the patient had a loss of therapeutic benefit.The event date was asked but unknown.It was indicated that it was not applicable if there were any environmental, external, or patient factors that may have led or contributed to the issue.It was reported that as diagnostics/troubleshooting performed, the catheter was assessed, and patency was unable to be established.As an action/intervention taken to resolve the issue, the catheter and pump were both replaced on (b)(6)2018.Surgical intervention occurred.It was noted that the catheter was replaced, and the physician also chose to replace the pump at the patient¿s insistence.At the time of the report the issue was resolved, and the patient's status was listed as ¿alive ¿ no injury.¿ it was noted that the catheter would not be returned as it was discarded by the customer.No further complications were reported or anticipated.The patient¿s medical history and weight were asked but would not be made available due to a legal/confidential reason.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.

• 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: 7352860
• MDR Text Key: 102896406
• Report Number: 3004209178-2018-05354
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,Followup
• Report Date: 05/01/2018

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: 09/14/2018
• 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: 03/19/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/25/2018; 04/30/2018
• Supplement Dates FDA Received: 04/27/2018; 05/01/2018
• Date Device Manufactured: 03/18/2017
• 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: 71 YR