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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 03/13/2024
Event Type  malfunction  
Event Description
It was reported that, this cardiac resynchronization therapy defibrillator (crt-d) exhibited high shock lead impedances out of range.All other measurements were within normal limits.Technical services (ts) provided troubleshooting options.This crt-d remains in service.No adverse patient effects were reported.
 
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Brand Name
RESONATE X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 Key18987286
MDR Text Key338720216
Report Number2124215-2024-18528
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/19/2022
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number249723
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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