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

Model Number DTBB2QQ

Device Problems Mechanical Problem (1384); Misconnection (1399); Component Missing (2306)

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

Event Date 04/22/2014

Event Type  malfunction  

Event Description

It was reported that during implant of a new device, it was noted that the left ventricular (lv) lead and right ventricular (rv) lead were connected in the wrong ports of the device.A wrench was used to remove the leads.Reconnection was attempted, however the torque wrench was unable to be used for the rv port.In addition, it was noted that the setscrew had fallen out and was unable to be found.The device was removed and a backup device was immediately used.The torque wrench was connected using a screw of the atrial port and was able to rotate in a normal manner.The device remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

• Brand Name: VIVA QUAD S
• 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: 3864870
• MDR Text Key: 4568520
• Report Number: 9614453-2014-01486
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: DTBB2QQ
• Device Catalogue Number: DTBB2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 06/10/2014
• Date Device Manufactured: 09/27/2013
• 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 Age: 00059 YR