MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number MDT-LEAD

Device Problems Signal Artifact/Noise (1036); Break (1069); Fracture (1260); Mechanical Problem (1384); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Defective Device (2588); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 01/01/1984

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.Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique manufacturer/device serial numbers.Patient information is limited due to confidentiality concerns.The baseline gender is not known, and the average age was 57 years.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.Lead model numbers include 6999, 6936, 6966, 6897, 6921, 6917, and 5866.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Incidence of icd lead related complications during long-term follow-up: comparison of epicardial and endocardial electrode systems pacing and clinical electrophysiology.1995; 18(11):2053-2061 doi: 10.1111/j.1540-8159.1995.Tb03867.X.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding epicardial and endocardial leads.The authors discussed cases where there were fractures of subcutaneous patch leads, dislodgement of superior vena cava (svc) leads, dislodgements of right ventricular leads, insulation breakage of sensing electrodes, epicardial insulation defects, connector defects, adapter defect of sensing leads, crinkling of patch leads, silicone rubber insulation defects of epicardial sensing leads, insulation breakage of a sensing electrode, shock therapies during sinus rhythm from a purely epicardial lead system, y adaptor defects in epicardial sensing leads and electrical noise, inappropriate therapies during sinus rhythm due to electrical artifacts, complete fracture of subcutaneous patches with significant rises in the defibrillation thresholds, and svc lead dislodgment into the right atrium.Surgical intervention was required.The status/disposition of the leads is not known.For the patients that received inappropriate shock therapy, no further patient complications have been reported.Further follow up did not yet yield any additional information.

• Brand Name: MEDTRONIC LEAD
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10497760
• MDR Text Key: 205883688
• Report Number: 2182208-2020-01764
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-LEAD
• Device Catalogue Number: MDT-LEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2020
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR