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

Model Number G156

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's left ventricular (lv) lead, exhibited a capture threshold increase from 2v to 3v, loss of capture (loc), and high out-of-range pace impedance measurements.Technical services (ts) recommended lead evaluation in clinic.Additional information received indicated that the patient was seen in clinic, and the shock vector was reprogrammed from lvtip1 to lvring2, to lvtip1 to lvring3.Impedances were checked again on january 1, 2021, and pace impedance values was 1,244 ohms and within normal limits.This device remains in service, and the patient will continue to be monitored remotely.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 this cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's left ventricular (lv) lead, exhibited a capture threshold increase from 2v to 3v, loss of capture (loc), and high out-of-range pace impedance measurements.Technical services (ts) recommended lead evaluation in clinic.Additional information received indicated that the patient was seen in clinic, and the shock vector was reprogrammed from lvtip1 to lvring2, to lvtip1 to lvring3.Impedances were checked again on january 1, 2021, and pace impedance values was 1,244 ohms and within normal limits.This device remains in service, and the patient will continue to be monitored remotely.No adverse patient effects were reported.

• Brand Name: DYNAGEN 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: 11211597
• MDR Text Key: 228169876
• Report Number: 2124215-2021-01281
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2015
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 100387
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR