MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION

Model Number NEU_EPIDURALNEEDLE

Device Problem Difficult to Remove (1528)

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

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis of the epidural needle found the spoon of the needle had a sharp edge on the undercut side.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative.It was reported that the surgeon passed the lead through the end of the included curved tip needle.In the course of placing the lead, the surgeon attempted to slightly withdraw the lead and it got stuck in the tip of the needle.The surgeon had to remove the needle and forcefully free the lead from needle.Additional information was received from a manufacture representative (rep) on (b)(6) 2017.The rep stated that the cause remains unknown so the item would be returned on (b)(6) 2017.The lead, stylet, and epidural needle were received for analysis on (b)(6) 2017.There were no patient symptoms reported and no complications reported.

Manufacturer Narrative

Correction: this event was captured in regulatory report 2649622-2018-08968.No further regulatory reports will be submitted under report number 3007566237-2018-01610, and future regulatory reports will only be submitted under regulatory report 2649622-2018-08968.If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7552542
• MDR Text Key: 109642134
• Report Number: 3007566237-2018-01610
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/30/2018

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
• Device Operator: Health Professional
• Device Model Number: NEU_EPIDURALNEEDLE
• Device Catalogue Number: NEU_EPIDURALNEEDLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 57 YR