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

Model Number 8731SC

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine at an unknown dose and concentration. The indication for use was not reported. It was reported that during catheter placement, the physician could not reach the subarachnoid space. The physician found that the catheter tip was deformed and bent. The tip of the tuohy needle bent during the procedure. It was clarified that both the catheter and the tuohy needle were bent. The customer discarded the catheter, and another kit was used; the procedure was performed with success. The issue was resolved. The patient's status was alive - no injury. There were no other issues reported with regards to why the physician could not reach the subarachnoid space. It was noted that the physician did not implant a pump, and currently the catheter was connected to an access port. No surgical intervention occurred, and no surgical intervention was planned. Information regarding the patient¿s gender, age, weight, medical history, and other medications was unavailable. No further complications were reported.

• 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: 9483738
• MDR Text Key: 177128627
• Report Number: 3004209178-2019-24005
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/10/2020
• Device Model Number: 8731SC
• Device Catalogue Number: 8731SC
• Device Lot Number: 0216093993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial