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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G447
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2024
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had triggered code 1007 due to capacitor charge time exceeding limitations.The charge times were found to be greater than 45 seconds.Just prior to this the estimated longevity of the product was 7.5 years.Engineering review of device data was completed, and a device reset was found along with a battery status of end of life (eol) in addition to the code 1007.It was also found that the device battery is not prematurely depleted given the high outputs and device programming.It was recommended that the product be explanted and replaced.Subsequently, this patient underwent a replacement procedure, and this product was successfully replaced.No additional adverse patient effects outside of the revision procedure were reported.
 
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Brand Name
RESONATE 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 Key18804610
MDR Text Key336506411
Report Number2124215-2024-12137
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/25/2023
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number263312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age73 YR
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