MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G151

Device Problems Over-Sensing (1438); Pocket Stimulation (1463); Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this system exhibited oversensing potentially due to the interaction between minute ventilation (mv) and respiratory rate trend (rrt).All lead measurements were within normal limits.A boston scientific technical services consultant suggested programming rrt off.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition and also exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection.Please see the description for more information regarding the specific circumstances of this event.

Event Description

This supplemental report is being filed to update the investigation conclusion code and additional manufacturing narrative.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this patient presented to the emergency room symptomatic as a result of extra cardiac stimulation.The patient recalled device reprogramming in the past due to the stimulation.A boston scientific technical services consultant identified an alert for an out of range pacing impedance measurement on the atrial channel.The presenting egm shows normal device operation.The consultant documented and discussed the clinical observations with the caller.No adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9973356
• MDR Text Key: 188065869
• Report Number: 2124215-2020-08085
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2019
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 123627
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR