MAUDE Adverse Event Report: MEDTRONIC, INC. VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA2QQ

Device Problems Failure to Capture (1081); Over-Sensing (1438)

Patient Problem Heart Failure (2206)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant product: 4298-88 atrial lead.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: device rounds: t-wave oversensing: a cause of loss of cardiac resynchronization therapy.Indian pacing and electrophysiology journal.2016;16(5):175-178.

Event Description

A journal article was reviewed which contained information regarding this patient¿s implantable cardiac resynchronisation therapy with defibrillator (crt-d) system.The article reported that the patient presented with loss of biventricular pacing associated with heart failure symptoms.The electrocardiogram showed sinus rhythm with alternating wide unpaced and narrower paced qrs complexes.Device interrogation showed t-wave oversensing (twos) on all paced biventricular beats.Device reprogramming resolved the twos.At the three-month check-up, the patient¿s hf symptoms had improved.The system remains in use.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• Brand Name: VIVA QUAD XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6468470
• MDR Text Key: 72077699
• Report Number: 2182208-2017-00534
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTBA2QQ
• Device Catalogue Number: DTBA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• 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: 6935 IMPLANTABLE TACHY LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR