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

Model Number	8578
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 8637-40, serial#: (b)(4), implanted: (b)(6) 2020, product type: pump.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On (b)(6) 2020, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving compounded baclofen (50 mcg/ml, 24.599 dose), fentanyl (28 mcg/ml, 13.775 mcg dose) and bupivacaine (12 mg/ml, 5.9 mg dose) via an implantable pump for non-malignant pain.It reported that during a procedure, the physician was unable to aspirate catheter so they wanted to replace the connector.The physician was unable to flush it and requested another connector (this was reported as surgical intervention).The connector was never implanted, another connector was used and implanted.The issue was resolved at the time of this report.The issue was resolved at the time of this report.The patient's status was alive - no injury.On 2020-jan-27, additional information was received.The rep reported the procedure was a pump replacement.They were unable to aspirate the catheter and the physician wanted to check the sutureless connector before proceeding with back table prime.
Additional Manufacturer Narrative
Analysis of the catheter revealed a non-significant finding of dried drug, blood, or foreign material occlusion in the catheter body.Concomitant medical products: product id 8637-40 serial# (b)(4) implanted: (b)(6)2020 product type pump.

• Brand Name: INFUSION CATHETER
• Common Device Name: 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
• MDR Report Key: 9668908
• Report Number: 3004209178-2020-02577
• Device Sequence Number: 19466649
• Product Code: LKK
• UDI-Device Identifier: 00643169887633
• UDI-Public: 00643169887633
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2021
• Device Model Number: 8578
• Device Catalogue Number: 8578
• Device Lot Number: HG3P7XB03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR