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

Model Number D224TRK

Device Problems Premature Discharge of Battery (1057); Output above Specifications (1432)

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

Event Date 04/24/2014

Event Type  Injury  

Event Description

It was reported the device battery depleted prematurely.It was also reported the left ventricular outputs were high.The device was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Concomitant product: 4196-88 lead implanted (b)(6) 2011.(b)(4).

• 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 DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3864785
• MDR Text Key: 20453985
• Report Number: 3004209178-2014-11362
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2014

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 Expiration Date: 04/28/2012
• Device Model Number: D224TRK
• Device Catalogue Number: D224TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 06/10/2014
• Date Device Manufactured: 11/10/2010
• 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: 5068-52 LEAD, 6945-65 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00062 YR