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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 G150
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Failure to Read Input Signal (1581); Under-Sensing (1661); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2022
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's right atrial (ra) lead, exhibited high out-of-range pace impedance measurements greater that 3,000 ohms, low p-wave amplitudes, and oversensed atrial noise.It was suspected that the out-of-range pace impedance measurements were likely attributed to the lead-header spring contact interaction.The crt-d is programmed to vvir, however atrial discriminators remain programmed on.As a result, inappropriate anti-tachycardia pacing (atp) therapy was delivered due to atrial noise and ventricular fibrillation (vf) undersensing occurred resulting in a delay to the delivery of shock therapy.It was noted that the patient was in the emergency room.This crt-d system remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d), implanted with another manufacturer's right atrial (ra) lead, exhibited high out-of-range pace impedance measurements greater that 3,000 ohms, low p-wave amplitudes, and oversensed atrial noise.It was suspected that the out-of-range pace impedance measurements were likely attributed to the lead-header spring contact interaction.The crt-d is programmed to vvir, however atrial discriminators remain programmed on.As a result, inappropriate anti-tachycardia pacing (atp) therapy was delivered due to atrial noise and ventricular fibrillation (vf) undersensing occurred resulting in a delay to the delivery of shock therapy.It was noted that the patient was in the emergency room.This crt-d system remains in service.No adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key15879728
MDR Text Key307589505
Report Number2124215-2022-49691
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534614
UDI-Public00802526534614
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2022
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 Lay User/Patient
Device Expiration Date06/12/2019
Device Model NumberG150
Device Catalogue NumberG150
Device Lot Number486963
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2022
Initial Date FDA Received11/29/2022
Supplement Dates Manufacturer Received12/14/2022
Supplement Dates FDA Received12/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2017
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age72 YR
Patient SexMale
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