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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 Difficult to Insert (1316); Material Integrity Problem (2978)
Patient Problems No Code Available (3191); Insufficient Information (4580)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that during the implant procedure when the physician experienced difficulty inserting the left ventricular (lv) lead into the header of the cardiac resynchronization therapy defibrillator (crt-d).A new lead was attempted with the same result.It was noted that lead was not able to be implanted due to patient anatomy.The setscrew was noted to be in the up position.The physician then removed the existing crt-d and put in a new device with the same model number.The original lv lead was successfully implanted and inserted into the header of the new crt-d without incident.No adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.During analysis an is4 lead was inserted into the lv lead port.The lead was successfully inserted and set screw was able to be secured.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis was unable to confirm the field allegations during testing.
 
Event Description
It was reported that during the implant procedure when the physician experienced difficulty inserting the left ventricular (lv) lead into the header of the cardiac resynchronization therapy defibrillator (crt-d).A new lead was attempted with the same result.It was noted that lead was not able to be implanted due to patient anatomy.The setscrew was noted to be in the up position.The physician then removed the existing crt-d and put in a new device with the same model number.The original lv lead was successfully implanted and inserted into the header of the new crt-d without incident.No adverse patient effects 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
MDR Report Key10638812
MDR Text Key210210206
Report Number2124215-2020-19775
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526589539
UDI-Public00802526589539
Combination Product (y/n)N
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/05/2022
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number238691
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2020
Initial Date Manufacturer Received 09/17/2020
Initial Date FDA Received10/06/2020
Supplement Dates Manufacturer Received04/07/2021
Supplement Dates FDA Received07/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
Patient Weight91
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