MAUDE Adverse Event Report: MEDTRONIC, INC. VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hematoma (1884); Perforation (2001); Perforation of Vessels (2135); Cardiac Tamponade (2226); Injury (2348); Diminished Pulse Pressure (2606); Pericardial Effusion (3271)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4195 implantable pacing lead.This information is based entirely on journal literature.Patient information is limited due to confidentiality concerns.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.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: a case of arterial and venous tear during single lead extraction.Case reports in cardiology.2016;2016(3836754):2090-6404.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 this patient¿s implantable cardioverter defibrillator (icd) system.The article indicated that the patient was admitted for a lead extraction and device upgrade.The author indicated that the lead was being replaced due to an apparent fracture from an insulation break at the same time of the device upgrade procedure.Of note, the lead had been cut and capped two months earlier.The article described the procedure with the chronic lead and remnant being removed ¿without difficulty.¿ however, during the procedure, the patient¿s blood pressure was unstable.Pericardial effusion and pericardial tamponade was discovered.Pericardiocentesis was performed.The patient¿s blood pressure ¿responded,¿ however, it began to decrease again, and deteriorated such that the patient went into cardiac arrest and required cardiopulmonary resuscitation.While the patient was still in the electrophysiology suite, an open chest sternotomy and evacuation of a hematoma was performed.Also noted was a large amount of clot removed from behind the heart.There was also bleeding noted.The patient was then transferred to the operating room and placed on cardiopulmonary bypass equipment.Exploratory surgery of the heart was conducted.¿several injuries¿ were noted with a large amount of bleeding.There was also a hematoma covering a tear in the vein where it crossed the aorta.There were two puncture injuries to the heart and the author noted were ¿likely associated with pericardiocentesis.¿ once the patient stabilized, the physician recommended replacement of the generator to the remaining right atrial and ventricular leads, with a future device upgrade to a bi-ventricular device.The procedure was ¿successfully completed.¿ further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: VIVA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 6006850
• MDR Text Key: 56797291
• Report Number: 2182208-2016-02349
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060039
• 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
• Report Date: 07/01/2016

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: DTBA1D1
• Device Catalogue Number: DTBA1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: 07/01/2016
• Supplement Dates FDA Received: 09/24/2017
• 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 PACING LEAD-VENTRICULAR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR