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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G158
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Telemetry Discrepancy (1629)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been returned for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that prior to the attempted implant of this cardiac resynchronization therapy defibrillator (crt-d), the device was having telemetry issues.Then the device exhibited alert codes and was found to be operating in safety mode.A new device was implanted.No adverse patient effects were reported.
 
Event Description
It was reported that prior to the attempted implant of this cardiac resynchronization therapy defibrillator (crt-d), the device was having telemetry issues.Then the device exhibited alert codes and was found to be operating in safety mode.A new device was implanted.No adverse patient effects were reported.
 
Manufacturer Narrative
(b)(4).The device has been returned for analysis.This report will be updated upon completion of analysis.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that both brady and tachy therapy remained available.Review of device memory identified multiple errors recorded on october 12, 2020.The errors resulted in software resets performed in an attempt to correct an identified memory inconsistency.The cause of the memory inconsistency was not able to be determined through laboratory testing.
 
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Brand Name
DYNAGEN 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 Key11103820
MDR Text Key224899731
Report Number2124215-2020-22096
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534904
UDI-Public00802526534904
Combination Product (y/n)N
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/14/2021
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 Date07/02/2022
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number240319
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Initial Date Manufacturer Received 10/12/2020
Initial Date FDA Received01/02/2021
Supplement Dates Manufacturer Received07/28/2021
Supplement Dates FDA Received10/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age56 YR
Patient Weight68
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