MAUDE Adverse Event Report: IPG MFG SWITZERLAND VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA2QQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 08/30/2013

Event Type  Injury  

Event Description

It was reported that following the implant procedure, the patient developed a thrombosis in their subclavian and axillary veins.Echocardiogram showed complete obstruction of the subclavian and axillary veins.Patient is receiving subcutaneous medication and the implantable cardioverter defibrillator (icd) and leads remain in use.The patient is enrolled in the (b)(4) 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 medical products: 5076-52, implantable pacing lead, (b)(6) 2013; 6947m62, implantable tachy lead, (b)(6) 2013; 459888, implantable pacing lead, (b)(6) 2013.(b)(4).

• Brand Name: VIVA QUAD XT
• 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 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: 3616566
• MDR Text Key: 4159752
• Report Number: 9614453-2014-00248
• 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: 12/16/2013

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2014
• Device Model Number: DTBA2QQ
• Device Catalogue Number: DTBA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 02/08/2014
• Date Device Manufactured: 04/06/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00072 YR
• Patient Weight: 70