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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 Problems Signal Artifact/Noise (1036); High impedance (1291)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2021
Event Type  malfunction  
Manufacturer Narrative
The local area field representative was contacted for additional information.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) and right atrial (ra) lead exhibited high out-of-range pace impedance measurements greater than 3,000 ohms and very fine noise.The presenting electrogram (egm) showed odd atrial behavior and appeared as though the ra and right ventricular (rv) lead were reversed in the header, however the prior transmission proved otherwise.All leads were in the correct ports.In addition, there was no evidence of noise at the time of report.Ts recommended a chest x-ray to evaluate for any potential lead anomaly.The crt-d and ra lead remain in service at this time.No adverse patient effects were reported.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited high out-of-range pace impedance measurements greater than 3,000 ohms and very fine noise.The presenting electrogram (egm) showed odd atrial behavior and appeared as though the ra and right ventricular (rv) lead were reversed in the header, however the prior transmission proved otherwise.All leads were in the correct ports.In addition, there was no evidence of noise at the time of report.Ts recommended a chest x-ray to evaluate for any potential lead anomaly.The crt-d and ra lead remain in service at this time.No adverse patient effects were reported.Additional information received reported that the patient was seen in clinic and it was determined that the right atrial (ra) lead was fractured.An attempt was made to program around it, but ultimately it was decided to turn off ra pacing altogether.No adverse patient effects were reported.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited high out-of-range pace impedance measurements greater than 3,000 ohms and very fine noise.The presenting electrogram (egm) showed odd atrial behavior and appeared as though the ra and right ventricular (rv) lead were reversed in the header, however the prior transmission proved otherwise.All leads were in the correct ports.In addition, there was no evidence of noise at the time of report.Ts recommended a chest x-ray to evaluate for any potential lead anomaly.The crt-d and ra lead remain in service at this time.No adverse patient effects were reported.Additional information received reported that the patient was seen in clinic and it was determined that the right atrial (ra) lead was fractured.An attempt was made to program around it, but ultimately it was decided to turn off ra pacing altogether.No 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 Key11232864
MDR Text Key228846238
Report Number2124215-2021-02022
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
Type of Report Initial,Followup,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/26/2022
Device Model NumberG151
Device Catalogue NumberG151
Device Lot Number142001
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age85 YR
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