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

Model Number D234TRK

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 06/17/2011

Event Type  Injury  

Event Description

It was reported that the patient received an inappropriate shock for atrial flutter.The patient¿s medication was adjusted and the implantable cardioverter defibrillator (icd) was reprogrammed and remains in use.The patient is enrolled in the (b)(6) clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the u.S., however, it is similar to a device marketed in the u.S.The event occurred outside the us and is being reported due to an alleged malfunction.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Concomitant products: mdt-lead, (b)(6) 2011.A 5076-52 lead.(b)(6) 2011.(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: 4606475
• MDR Text Key: 5761598
• Report Number: 9614453-2015-00536
• 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
• Type of Report: Initial
• Report Date: 06/21/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2012
• Device Model Number: D234TRK
• Device Catalogue Number: D234TRK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2011
• Date Device Manufactured: 02/07/2011
• 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: 419688 LEAD
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 00059 YR