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

Model Number G151

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Pocket Stimulation (1463); Failure to Read Input Signal (1581); Connection Problem (2900); High Capture Threshold (3266)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

This device is expected to be returned for evaluation.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient's competitive left ventricular (lv) lead had been programmed off due to no capture despite maximum device outputs in unipolar configuration and the patient was experiencing pocket stimulation.Review of the stored data identified an alert for out-of-range lv intrinsic amplitudes, noise and elevated threshold measurements.Pacing impedance measurements were jumpy, and a previous lead safety switch (lss) had occurred due to an lv pacing impedance measurement greater than 3000 ohms.A boston scientific technical services consultant noted the implanted boston scientific device does not have the enhanced header and discussed a potential lead to device connection issue or lead fracture.A revision procedure was performed, and stable lv pacing impedance and threshold measurements were confirmed.Therefore, the physician elected to replace this device and continue to lead the current competitive lv lead implanted.This lead was interfaced to the new device and the numbers were consistent and solid.The explanted device will be returned for evaluation.No additional 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19139578
• MDR Text Key: 340541381
• Report Number: 2124215-2024-23732
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2019
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 124644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male