MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; IMPLANTABLE DEVICE

Model Number G138

Device Problems High impedance (1291); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  malfunction  

Event Description

It was reported that during an implant procedure of a cardiac resynchronization therapy defibrillator (crt-d) device there were observations of high out-of-range pacing impedances on the left ventricular (lv) lead measuring greater than 3000 ohms.Technical services (ts) recommended to reconnect the lead into the device header and impedances measured in the 2000 ohms range.Additionally, ts recommended to test with the pacing system analyzer (psa) however, the physician elected to leave it connected and programmed to a vector and impedances were within range.This crt-d and lv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that during an implant procedure of a cardiac resynchronization therapy defibrillator (crt-d) device there were observations of high out-of-range pacing impedances on the left ventricular (lv) lead measuring greater than 3000 ohms.Technical services (ts) recommended to reconnect the lead into the device header and impedances measured in the 2000 ohms range.Additionally, ts recommended to test with the pacing system analyzer (psa) however, the physician elected to leave it connected and programmed to a vector and impedances were within range.This crt-d and lv lead remains in service.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.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that during an implant procedure of a cardiac resynchronization therapy defibrillator (crt-d) device there were observations of high out-of-range pacing impedances on the left ventricular (lv) lead measuring greater than 3000 ohms.Technical services (ts) recommended to reconnect the lead into the device header and impedances measured in the 2000 ohms range.Additionally, ts recommended to test with the pacing system analyzer (psa) however, the physician elected to leave it connected and programmed to a vector and impedances were within range.This crt-d and lv lead remains in service.No adverse patient effects were reported.It was determined that the high out-of-range pacing impedances on the lv lead was not associated with the device's spring contact and lead terminal ring as previously reported.As all available evidence indicates the cause of the event was due to the lv lead and not the device, this event is no longer deemed to be a reportable incident.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11668693
• MDR Text Key: 245522667
• Report Number: 2124215-2021-06535
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

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: 01/20/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 387205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/19/2021; 09/09/2021
• Supplement Dates FDA Received: 06/24/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR