MAUDE Adverse Event Report: MEDTRONIC, INC. SCREW-IN TEMPORARY LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6416

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/27/2006

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The baseline gender characteristic is male for the patients referenced in the article.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: ¿one-year follow-up in a prospective, randomized study comparing radiofrequency and cryoablation of arrhythmias in koch¿s triangle: clinical symptoms and event recording.¿ europace (2006) 8, 592¿595.Doi:10.1093/europace/eul051.

Event Description

The literature publication reports the following patient complications during an ablation procedure: there was one (1) patient who had a cardiac tamponade due to a temporary transvenous, active fixation lead.There was no treatment/resolution indicated by the author.The status/location of the lead is unknown.No further patient complications have been reported as a result of this event.

• Brand Name: SCREW-IN TEMPORARY LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6922867
• MDR Text Key: 88431859
• Report Number: 2182208-2017-01596
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K973360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6416
• Device Catalogue Number: 6416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• 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
• Treatment: ABLATION CATHETER
• Patient Outcome(s): Life Threatening