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

Model Number MDT-LEAD

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Death (1802); Embolus (1830); Hematoma (1884); Hemothorax (1896); Unspecified Infection (1930); Myocardial Infarction (1969); Pneumothorax (2012); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Injury (2348); Obstruction/Occlusion (2422); Cardiac Perforation (2513); Exit Block (2628)

Event Date 01/01/2016

Event Type  Death  

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.Patient information is limited due to confidentiality concerns.The gender of the baseline characteristics of the patients referenced in the article is male.The date of death is not available at the time of this report, as there is no indication of specific serial number/patient information.Without the specific model number(s), it is not possible to assure the specific product correction number referenced in the article is listed in this report.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: outcomes 1 year after implantable cardioverter-defibrillator lead abandonment versus explantation for unused or malfunctioning leads.Circulation: arrhythmia and electrophysiology.2016;9(7):1941-3149.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding implantable tachy leads.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article indicated that there were patient deaths referenced.Of note, there is no indication in the article that the deaths were lead-related.The article also reports that there were lead ¿failures or malfunctions,¿ which included dislodgement, a possible set screw problem, and recalled leads.There were multiple ¿in-hospital complications,¿ which included cardiac attest, cardiac perforation, valve injury, cardiac perforation, hemothorax, pericardial tamponade, pneumothorax, myocardial infarction, transient ischemic attack (tia)/stroke, ¿urgent cardiac surgery,¿ hematoma requiring intervention, infection requiring antibiotics, peripheral embolus, and venous obstruction.It was not possible to ascertain specific lead information from the literature publication.The status of the leads is unknown.Further follow up did not yet yield any additional information.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This information is based entirely on journal literature and the subsequent follow up information obtained.All information provided is included in this report.

Event Description

Additional information was obtained through follow up with the author.The author stated that they ¿cannot comment on specific adverse events (including death) since we did not examine events on a patient or device specific basis.In other words, we did not correlate specific adverse events to a specific patient or a specific device.So, it is possible that adverse events (including death) were related to medtronic products, but none of our analyses included that level of detail.¿ no further information was available.

Manufacturer Narrative

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

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5930296
• MDR Text Key: 53973812
• Report Number: 2182208-2016-02196
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided; 10/24/2016
• Supplement Dates FDA Received: 11/22/2016; 09/25/2017
• 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: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention