MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO CONSULTA CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D234TRK

Device Problems Invalid Sensing (2293); Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Shock (2072); Dizziness (2194)

Event Date 10/24/2011

Event Type  Injury  

Event Description

It was reported that the patient received an inappropriate shock due to atrial fibrillation and the implantable cardioverter defibrillator (icd) exhibiting a detection problem.The patient experienced symptoms of dizziness, arrhythmia and atrial fibrillation.Intervention was required and the patient's medication was adjusted.The icd remains in use.No patient complications have been reported as a result of this event.Patient is enrolled in the optilink hf study.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Concomitant products: 407652 lead, implanted: (b)(6) 2011; a 419488 lead, implanted: (b)(6) 2011.(b)(4).

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the unexpected delivery of a ventricular tachyarrthymia (vt) therapy.Vt episode #1088 detected vt and withheld for atrial fibrillation for one interval.

Manufacturer Narrative

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

• Brand Name: CONSULTA CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4682188
• MDR Text Key: 5693048
• Report Number: 3004209178-2015-07086
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2012
• Device Model Number: D234TRK
• Device Catalogue Number: D234TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2010
• 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: 6947 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00063 YR