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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 Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2020
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) did not end an initiated intrinsic amplitude measurement test (even after telemetry with the programmer was interrupted by ending the session) and had to be re-interrogated to restore normal device operation.Technical services (ts) reviewed available device data and did not find any resets or abnormal faults.However, ts recommended a more detailed troubleshooting approach and requested the clinic provide both device and programmer data for review.There were no adverse patient effects reported.At this time, the crt-d remains implanted and in service.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.Should additional follow-up information be provided, a supplemental report will be issued.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) did not end an initiated intrinsic amplitude measurement test (even after telemetry with the programmer was interrupted by ending the session) and had to be re-interrogated to restore normal device operation.Technical services (ts) reviewed available device data and did not find any resets or abnormal faults.However, ts recommended a more detailed troubleshooting approach and requested the clinic provide both device and programmer data for review.There were no adverse patient effects reported.At this time, the crt-d remains implanted and in service.Additional information received from the field indicates that boston scientific engineering reviewed device data and did not find any resets or abnormal results, and concluded the implanted device appeared to be operating normally.The advice to remedy the condition has already been carried out by the account and there has been no report of any further issues.
 
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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 Key11104409
MDR Text Key224826841
Report Number2124215-2020-25616
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,foreig
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/29/2020
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number205045
Was Device Available for Evaluation? No
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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