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

Model Number D364TRG

Device Problems Over-Sensing (1438); Defibrillation/Stimulation Problem (1573); Invalid Sensing (2293)

Patient Problems Atrial Tachycardia (1731); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: linox smart lead, implanted: (b)(6) 2012.Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated there was a pr logic detection.The supra ventricular (svt) limit was programmed to 260ms and the ventricular median rate of the arrhythmia was 250ms which caused wavelet to stop withholding and provide therapy.Analysis of the device memory indicated an inappropriate vf detection.Analysis of the device memory indicated oversensing due to emi (electromagnetic interference)/noise.Analysis of the device memory indicated the unexpected delivery of a ventricular tachyarrhythmia therapy.

Event Description

It was reported that the patient experienced atrial fibrillation (af) and ventricular fibrillation (vf) and all six high voltage therapies that were delivered were ineffective.It was noted the defibrillation shocks were not effective due to the presence of sinus tachycardia and wavelet withheld therapy.It was noted the patient was hospitalized and the physician performed ablation therapy, which resulted in an external signal being recognized as ventricular fibrillation (vf).The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: PROTECTA 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): 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: 6160240
• MDR Text Key: 62334282
• Report Number: 9614453-2016-06753
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2017
• Device Model Number: D364TRG
• Device Catalogue Number: D364TRG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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: 4194-78 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention