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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G151
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Unspecified Infection (1930); Sepsis (2067)
Event Date 09/05/2019
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) was in atrial fibrillation (af).Also, the patient developed infection with sepsis.As of this time, the crt-d remains in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) was in atrial fibrillation (af).Also, the patient developed infection with sepsis.As of this time, the crt-d remains in service.No additional adverse patient effects were reported.
 
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Brand Name
DYNAGEN 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 Key9286159
MDR Text Key165289889
Report Number2124215-2019-24430
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534638
UDI-Public00802526534638
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 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/01/2019
Device Model NumberG151
Device Catalogue NumberG151
Device Lot Number125246
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age76 YR
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