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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)
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BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) Back to Search Results
Model Number G547
Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Arrhythmia (1721); Electric Shock (2554)
Event Date 11/11/2023
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a fault code.For patient protection the device was switched to safety mode.Technical services (ts) reviewed and stated that device will need to be replaced.The physician asked ts on how to turn tachy therapy off as the patient had received few shocks.The parameters including unipolar rv sensing and pacing at automatic gain control (agc) were reviewed and noticed pauses in pacing.The temporary wire was introduced, the patient went into ventricular tachycardia (vt).It took around 20 shocks to convert the vt.Upon review, it was stated that the shock delivered while patient at home was due to the oversensing, however ts were not able to confirm that.The plan is to replace this device and send back for analysis.This device currently remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
This report captures the explant of this device and impact on the patient.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a fault code.For patient protection the device was switched to safety mode.Technical services (ts) reviewed and stated that device will need to be replaced.The physician asked ts on how to turn tachy therapy off as the patient had received few shocks.The parameters including unipolar rv sensing and pacing at automatic gain control (agc) were reviewed and noticed pauses in pacing.The temporary wire was introduced, the patient went into ventricular tachycardia (vt).It took around 20 shocks to convert the vt.Upon review, it was stated that the shock delivered while patient at home was due to the oversensing, however ts were not able to confirm that.The plan is to replace this device and send back for analysis.This device currently remains in service.No adverse patient effects were reported.Additional information received indicated this device was explanted and during the first attempt, the patient was placed on the table for placement of a transvenous pacing (tvp) as the patient was dependent.When placing the tvp wire, the patient went into ventricular fibrillation (vf) and had to be externally shocked multiple times with cardiopulmonary resuscitation (cpr) for resuscitation.This was not caused by the device but happened at the time of an unexpected device replacement.This device is expected to return for analysis.No additional patient adverse effects were reported.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.This report captures the explant of this device and impact on the patient.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a fault code.For patient protection the device was switched to safety mode.Technical services (ts) reviewed and stated that device will need to be replaced.The physician asked ts on how to turn tachy therapy off as the patient had received few shocks.The parameters including unipolar rv sensing and pacing at automatic gain control (agc) were reviewed and noticed pauses in pacing.The temporary wire was introduced, the patient went into ventricular tachycardia (vt).It took around 20 shocks to convert the vt.Upon review, it was stated that the shock delivered while patient at home was due to the oversensing, however ts were not able to confirm that.The plan is to replace this device and send back for analysis.This device currently remains in service.No adverse patient effects were reported.Additional information received indicated this device was explanted and during the first attempt, the patient was placed on the table for placement of a transvenous pacing (tvp) as the patient was dependent.When placing the tvp wire, the patient went into ventricular fibrillation (vf) and had to be externally shocked multiple times with cardiopulmonary resuscitation (cpr) for resuscitation.This wasn't caused by the device but happened at the time of an unexpected device replacement.This device is expected to return for analysis.No additional patient adverse effects were reported.
 
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Brand Name
RESONATE HF CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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 Key18149842
MDR Text Key328296615
Report Number2124215-2023-64669
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/07/2023
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 NumberG547
Device Catalogue NumberG547
Device Lot Number289042
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/11/2023
Initial Date FDA Received11/16/2023
Supplement Dates Manufacturer Received11/21/2023
12/07/2023
Supplement Dates FDA Received11/21/2023
12/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2022
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; Other; Required Intervention;
Patient Age76 YR
Patient SexMale
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