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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); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Fall (1848); Electric Shock (2554); No Code Available (3191)
Event Date 07/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room after a fall and receiving two shocks.The shock therapy was felt to be inappropriate due to potential rapid ventricular response.Interrogation of the device with a programmer found the device was in safety mode and the device had recorded three messages indicating a potential memory anomaly.Device replacement was recommended.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Manufacturer Narrative
F10: patient code 3191 captures the reportable event of surgery.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 an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.
 
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room after a fall and receiving two shocks.The shock therapy was felt to be inappropriate due to potential rapid ventricular response.Interrogation of the device with a programmer found the device was in safety mode and the device had recorded three messages indicating a potential memory anomaly.Device replacement was recommended.Surgical intervention was undertaken.The device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
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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 Key10618139
MDR Text Key209564646
Report Number2124215-2020-16057
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,health
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/26/2020
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number196938
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Initial Date Manufacturer Received 07/19/2020
Initial Date FDA Received10/01/2020
Supplement Dates Manufacturer Received04/01/2021
Supplement Dates FDA Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
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