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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEFIBRILLATOR Back to Search Results
Model Number G447
Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)
Patient Problems Electric Shock (2554); Syncope/Fainting (4411)
Event Date 03/01/2023
Event Type  Injury  
Event Description
It was reported that this cardiac re-synchronization therapy defibrillator (crt-d) delivered inappropriate therapy to the patient during an intrinsic ventricular tachycardia storm.Five months later the patient experienced a syncope episode and was transported to the hospital, analysis of the device was performed and it was found that the device recorded a code 1007 indicative of the capacitor charge time exceeding the limit.Additionally, it was determined that the battery of the device had been depleted, raising suspicions of premature battery depletion.It was decided to explant and replace this device.This device is expected to be returned to boston scientific for analysis.No further adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy to the patient during an intrinsic ventricular tachycardia storm.Five months later the patient experienced a syncope episode and was transported to the hospital, analysis of the device was performed and it was found that the device recorded a code 1007 indicative of the capacitor charge time exceeding the limit.Additionally, it was determined that the battery of the device had been depleted, raising suspicions of premature battery depletion.It was decided to explant and replace this device.This device is expected to be returned to boston scientific for analysis.No further adverse patient effects were reported.
 
Manufacturer Narrative
Information was corrected from the following fields: d6b: explant date, g2: report source.
 
Manufacturer Narrative
The returned defibrillator was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy to the patient during an intrinsic ventricular tachycardia storm.Five months later the patient experienced a syncope episode and was transported to the hospital, analysis of the device was performed and it was found that the device recorded a code 1007 indicative of the capacitor charge time exceeding the limit.Additionally, it was determined that the battery of the device had been depleted, raising suspicions of premature battery depletion.It was decided to explant and replace this device.This device is expected to be returned to boston scientific for analysis.No further adverse patient effects were reported.
 
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Brand Name
RESONATE X4 CRT-D
Type of Device
IMPLANTABLE DEFIBRILLATOR
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 Key17638038
MDR Text Key322134362
Report Number2124215-2023-46414
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/14/2020
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number203459
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2018
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 Age84 YR
Patient SexFemale
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