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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 Problem Contamination /Decontamination Problem (2895)
Patient Problem Vascular Dissection (3160)
Event Date 09/07/2018
Event Type  Injury  
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was an attempted implant due to packaging contamination issues.During the surgical pocket closure, the left ventricular (lv) lead was pulled back which lead to a dissection of the patient's vein.Both devices were removed and replaced prior to pocket closure.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual inspection revealed the cardiac resynchronization therapy defibrillator (crt-d) package was not contaminated.The crt-d returned inside the sterile tray and was never implanted.Returned products test were completed to assess the device performance.Measurements throughout these tests were within normal limits.No anomalies were not found.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was an attempted implant due to packaging contamination issues.During the surgical pocket closure, the left ventricular (lv) lead was pulled back which lead to a dissection of the patient's vein.Both devices were removed and replaced prior to pocket closure.Additional information provided by a sales representative stated the device was not removed from the sterile packaging.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CLONMEL LIMITED
cashel road
,
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8046323
MDR Text Key126391566
Report Number2124215-2018-61412
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534904
UDI-Public00802526534904
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/30/2020
Device Model NumberG158
Device Catalogue NumberG158
Device Lot Number197075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age89 YR
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