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

Model Number G158

Device Problems Premature Discharge of Battery (1057); Delayed Charge Time (2586)

Patient Problem Atrial Fibrillation (1729)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the device was thoroughly inspected and analyzed.External visual inspection identified no anomalies.Review of device memory confirmed that the device had reached elective replacement indicator (eri) status due to long charge times.Testing confirmed that an internal component was not securely attached to the circuit substrate.This open connection was between a diode component within charging circuitry and the electronics substrate.This incomplete electrical pathway within the device's shock charging circuitry resulted in the lengthened charge times that triggered eri (note that the battery was not depleted, but replacement indicators were triggered because capacitor charging was not accomplished within the specified time).Engineers determined that the conductive epoxy used to connect the diode component to the printed circuit board did not create a secure connection.Despite exhibiting extended charge times, the maximum shock energy was still available and therapy availability is not compromised in devices exhibiting this issue.Therapy would have been available to the patient (if required), albeit with a somewhat longer charge time.This intermittent connection manifests during capacitor reformations or therapy charges.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to have reached the elective replacement indicator (eri) sooner than expected.Review of device information revealed that there had been two long charges generated during cardioversion of atrial fibrillation the day before eri was declared.The crt-d was explanted and replaced.The patient's leads remain in service with the new device.No additional 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8532231
• MDR Text Key: 142514575
• Report Number: 2124215-2019-07097
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2016
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 105857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR