MAUDE Adverse Event Report: IPG MFG SWITZERLAND VIVA XT CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number C6TR01

Device Problem Capturing Problem (2891)

Patient Problem Torsades-de-Pointes (2107)

Event Date 05/28/2016

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.No anomalies were found.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with torsades de pointes, and required external shock one time with cardiopulmonary resuscitation for several minutes.It was also noted that the previous device check showed sinus rhythm, although no atrial lead was placed.The torsades was initiated during the capture management testing, however it was unknown if the testing caused the torsades.The capture management for the patient's right ventricular (rv) lead and left ventricular (lv) lead was reprogrammed off.The rv lead was later capped, the lv lead remains in use and the device was explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.Analysis of the device memory was performed and no anomalies were found.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA XT CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5860715
• MDR Text Key: 51723543
• Report Number: 9614453-2016-05156
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2015
• Device Model Number: C6TR01
• Device Catalogue Number: C6TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• 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; Life Threatening; Required Intervention
• Patient Age: 68 YR