MAUDE Adverse Event Report: MEDTRONIC, INC.; WIRE, GUIDE, CATHETER

Model Number MDT-CATHETER

Device Problem Failure to Advance (2524)

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

Event Date 01/01/2018

Event Type  malfunction  

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.The baseline gender/age characteristic is male/(b)(6)years old.Of note, multiple patients were noted in the article; however, a one-to-one correlation could not be made with unique device serial numbers.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.Possible catheter models could include the following: c315; s4, s5, s10, j, h20, h40, his.C304; c340s59, c304l69.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: his-bundle pacing as a standard approach in patients with permanent atrial fibrillation and bradycardia.Pacing clin electrophysiol.2018; 41:1508¿1512.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding a pacing lead.The article compared the outcomes of his bundle (hb) pacing versus ventricular myocardial pacing.The information showed lower success rates for his bundle pacing due to higher thresholds, lower sensing, and a higher current drain.During the implant procedure mapping of the his bundle area failed and the sheath was replaced.After localization of the largest hb area the lead was screwed into position.Of the cases where failure to implant hb, the reasons were; inability to locate a hb potential, inability to fix the lead in the hb position, loss of hb capture after the sheath was removed, and poor sensing which resulted in the implant of an additional right ventricular lead.Long term complications were listed as loss of hb capture due to a rise in threshold, a significant rise in threshold without loss of hb pacing, a threshold rise, which was attributed to lead withdrawal (maybe due to insufficient suture tightening of the protective sleeve).In this last case, the lead was removed and replaced.In another case, one patient developed left bundle branch block, which was considered a possible complication of chronic hb pacing.Additionally, there were implant failures with one sheath, a different sheath was used and successful implant with the replaced sheath did not occur in all the cases.The status of the leads is unknown.Further follow-up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• Type of Device: WIRE, GUIDE, CATHETER
• 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: 8176653
• MDR Text Key: 130915236
• Report Number: 2182208-2018-02277
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT-CATHETER
• Device Catalogue Number: MDT-CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR