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

Model Number 8709SC

Device Problem Insufficient Information (3190)

Patient Problems Malaise (2359); Underdose (2542)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8637-40, serial#: (b)(4), implanted: (b)(6) 2019, product type: pump.Product id: 8637-40, serial#: (b)(4), implanted: (b)(6) 2019, product type: pump.Other relevant device(s) are: product id: 8637-40, serial/lot #: (b)(4), ubd: 14-oct-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient receiving morphine via an implantable infusion pump.It was reported that something happened to the catheter and the patient was no longer getting the full amount.It was noted that due to the issue the patient was getting sick.A replacement was planned but pending the approval of the patient's insurance.

• Brand Name: INDURA
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10682890
• MDR Text Key: 211461485
• Report Number: 3004209178-2020-17983
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169158092
• UDI-Public: 00643169158092
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2014
• Device Model Number: 8709SC
• Device Catalogue Number: 8709SC
• Device Lot Number: H842606405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2020
• Date Device Manufactured: 09/27/2012
• 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): Required Intervention
• Patient Age: 63 YR