MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARISMA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number G347

Device Problems Battery Problem (2885); Material Integrity Problem (2978)

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

Event Date 10/01/2023

Event Type  Injury  

Event Description

It was reported that the remaining estimated longevity of the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device decreased from 2 years to a year over the course of 5 months.A request was made to have data from this device analyzed.Data analysis has not been completed at this time.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

At this time, no further information is available.Should relevant additional information become available this report will be updated.

Manufacturer Narrative

At this time, no further information is available.Should relevant additional information become available this report will be updated.

Event Description

It was reported that the remaining estimated longevity of the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device decreased from 2 years to a year over the course of 5 months.A request was made to have data from this device analyzed.Data analysis has not been completed at this time.This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.

Event Description

It was reported that the remaining estimated longevity of the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device decreased from 2 years to a year over the course of 5 months.A request was made to have data from this device analyzed.Data analysis has not been completed at this time.This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device was subsequently explanted and replaced.During the procedure a black spot was noticed on the device header located at the right ventricular (rv) lead connection area.No additional adverse patient effects were reported.The device is expected to be returned for analysis.

• Brand Name: CHARISMA
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18083111
• MDR Text Key: 327486098
• Report Number: 2124215-2023-62371
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2024

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 Model Number: G347
• Device Catalogue Number: G347
• Device Lot Number: 291531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/23/2023; 01/23/2024
• Supplement Dates FDA Received: 11/23/2023; 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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; Required Intervention
• Patient Age: 75 YR