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

Model Number D224TRK

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 05/18/2011

Event Type  Injury  

Manufacturer Narrative

This report is based solely on reviewed clinical data from the device.If additional relevant information is received, a supplemental report will be submitted.Products: 6942-65, implantable tachy lead, 2002 (b)(6); 5068-45, implantable pacing lead, 2002 (b)(6); 419488, implantable pacing lead, 2004 (b)(6).(b)(4).This device was included in that field action.Based on the information received and without the return of the product, it could not determine this device performed as described in the field action.

Event Description

It was reported that product performance data was reviewed and classified as inappropriate therapy due to supra ventricular tachycar dia.The device remains in use.The patient was enrolled in the (b)(6) clinical study.No further patient complications have been reported as a result of this event.

• 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: 3768244
• MDR Text Key: 15882561
• Report Number: 3004209178-2014-07858
• 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: Study,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/23/2011

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: 12/14/2010
• Device Model Number: D224TRK
• Device Catalogue Number: D224TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2011
• Initial Date FDA Received: 04/23/2014
• Date Device Manufactured: 06/27/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0111-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 00084 YR