MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G138

Device Problems Device Sensing Problem (2917); Impedance Problem (2950); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Event Description

It was reported that this patient with a implantable cardioverter defibrillator (icd) device and competitors leads, reported on the home monitoring equipment a out of range pacing impedance on the right ventricular (rv) lead.The patient showed up at the clinic stating the device was beeping.It was noted that the right ventricular (rv) lead pacing impedance has been in a upward trend since (b)(6) 2020, an average of 450 ohms to 750 ohms.No episodes of noise, however an increase in thresholds from 0.7v to 1.2v.The physician performed some device manipulation and isometrics and could not recreate the episode.

Event Description

It was reported that this patient with a implantable cardioverter defibrillator (icd) device and competitors leads, reported on the home monitoring equipment an out of range pacing impedance on the right ventricular (rv) lead.The patient showed up at the clinic stating the device was beeping.It was noted that the right ventricular (rv) lead pacing impedance has been in a upward trend since (b)(6) 2020, an average of 450 ohms to 750 ohms.No episodes of noise, however an increase in thresholds from 0.7v to 1.2v.The physician performed some device manipulation and isometrics and could not recreate the episode.This device remains implanted.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.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

• Brand Name: MOMENTUM X4 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: 9947343
• MDR Text Key: 187188953
• Report Number: 2124215-2020-06788
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

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: Lay User/Patient
• Device Expiration Date: 11/22/2019
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 378841
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 05/26/2020
• Patient Sequence Number: 1