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 No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2018

Event Type  Injury  

Event Description

It was reported that the battery appeared to be depleting sooner than expected on this cardiac resynchronization therapy defibrillator (crt-d).On (b)(6) 2018 the battery longevity was at approximately 8 years.Then on (b)(6) 2018 the battery longevity was at approximately 7 and a half years remaining.It was also reported that on (b)(6) 2018, the device triggered the elective replacement indicator (eri), due to the auto capacitor reform confirmed charge time of approximately 22.4 seconds.Data analysis confirmed that the device appeared to have a hardware issue.The device was removed and replaced, and has been returned for analysis.This report will be updated, upon analysis completion.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the device was thoroughly inspected and analyzed.Review of device memory confirmed that the device had reached (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).Engineers determined that the conductive epoxy used to connect the diode component to the printed circuit board, did not create a secure connection.This intermittent connection manifests during capacitor reformations or therapy charges.Analysis has confirmed the clinical observations.

Event Description

It was reported that the battery appeared to be depleting sooner than expected on this cardiac resynchronization therapy defibrillator (crt-d).On (b)(6) 2018 the battery longevity was at approximately 8 years.Then on (b)(6) 2018 the battery longevity was at approximately 7 and a half years remaining.It was also reported that on (b)(6) 2018, the device triggered the elective replacement indicator (eri), due to the auto capacitor reform confirmed charge time of approximately 22.4 seconds.Data analysis confirmed that the device appeared to have a hardware issue.The device was removed and replaced, and has been returned for analysis.

• 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: 8215004
• MDR Text Key: 131999498
• Report Number: 2124215-2019-00043
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

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: 05/07/2016
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 105080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2014
• 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: 56 YR