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

Model Number	8709SC
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Malaise (2359); Underdose (2542)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10682890
• Report Number: 3004209178-2020-17983
• Device Sequence Number: 436751
• Product Code: LKK
• UDI-Device Identifier: 00643169158092
• UDI-Public: 00643169158092
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR