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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION CHARISMA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
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.
 
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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 Key18083111
MDR Text Key327486098
Report Number2124215-2023-62371
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
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 NumberG347
Device Catalogue NumberG347
Device Lot Number291531
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2023
Initial Date FDA Received11/07/2023
Supplement Dates Manufacturer Received11/23/2023
01/23/2024
Supplement Dates FDA Received11/23/2023
01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
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