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); Noise, Audible (3273)

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

Event Date 02/23/2023

Event Type  Injury  

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) was beeping.A request was made to have data from this device analyzed.Data analysis confirmed that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.The battery appeared to be depleting more quickly than expected.Engineering analysis confirmed premature battery depletion.Device replacement was recommended.At this time, this icd remains in service, and there were no adverse patient effects reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was beeping.A request was made to have data from this device analyzed.Data analysis confirmed that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.The battery appeared to be depleting more quickly than expected.Engineering analysis confirmed premature battery depletion.Device replacement was recommended.At this time, this icd remains in service, and there were no adverse patient effects reported.Additional information received indicated that this device was surgically explanted, and a new device was placed.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert (code 1003) was recorded.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised low voltage capacitors.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was beeping.A request was made to have data from this device analyzed.Data analysis confirmed that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.The battery appeared to be depleting more quickly than expected.Engineering analysis confirmed premature battery depletion.Device replacement was recommended.At this time, this icd remains in service, and there were no adverse patient effects reported.Additional information received indicated that this device was surgically explanted, and a new device was placed.No additional adverse patient effects 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16539578
• MDR Text Key: 311258606
• Report Number: 2124215-2023-11995
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2020
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 188910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female