MAUDE Adverse Event Report: IPG MFG SWITZERLAND CONSULTA CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D234TRK

Device Problems Nonstandard Device (1420); Invalid Sensing (2293)

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

Event Date 09/14/2011

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.As a result of the shock, the patient experienced pain.Intervention was required and the patient's medication was adjusted.The implantable cardioverter defibrillator (icd) remains in use.No patient complications have been reported as a result of this event.Patient is enrolled in the (b)(6) study.

Manufacturer Narrative

This model number is not approved for distribution in the united states; however, it is same/similar to a device marketed in the u.S.This event occurred outside the us and patient information is not generally available due to confidentiality concerns.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.Concomitant products: 694765 lead implanted: (b)(6) 2010; 5076-52 lead implanted: (b)(6) 2010.(b)(4).

• Brand Name: CONSULTA CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 4682189
• MDR Text Key: 5714969
• Report Number: 9614453-2015-00988
• 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
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/16/2011

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: 11/14/2011
• Device Model Number: D234TRK
• Device Catalogue Number: D234TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2011
• Date Device Manufactured: 05/20/2010
• 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
• Treatment: 429688 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00071 YR