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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 Problem High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2023
Event Type  malfunction  
Event Description
It was reported that at the procedure to implant this implantable device, an inquiry was received asking what lva pacing impedance of 900 ohms and lvb pacing impedance greater than 3000 ohms would indicate.It was noted that other vectors were not actually looked at as they were similar to the pacing system analyzer (psa).A boston scientific technical services consultant discussed device function, potential reasons for the out-of-range impedance measurements and recommended further troubleshooting.No adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that at the procedure to implant this implantable device, an inquiry was received asking what lva pacing impedance of 900 ohms and lvb pacing impedance greater than 3000 ohms would indicate.It was noted that other vectors were not actually looked at as they were similar to the pacing system analyzer (psa).A boston scientific technical services consultant discussed device function, potential reasons for the out-of-range impedance measurements and recommended further troubleshooting.No adverse patient effects were reported.This supplemental report is being processed to provide the implant date of this product.
 
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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 Key16455814
MDR Text Key310382865
Report Number2124215-2023-09428
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number297765
Was Device Available for Evaluation? No
Date Manufacturer Received04/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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