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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number D153
Device Problems High impedance (1291); Over-Sensing (1438); Defective Device (2588)
Patient Problems Palpitations (2467); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2020
Event Type  malfunction  
Event Description
It was reported that impedance on the right atrial (ra) channel of this implantable cardioverter defibrillator was high and out of range.The ra lead is from another manufacturer.Oversensing of signals from the respiratory rate trend (rrt) feature were noted on the ra channel.A technical services (ts) consultant discussed turning rrt off and noted that the reported clinical observations could be due to either a lead or a connection issue.Ts also suggested further system evaluation.The patient was seen in clinic and the noise could not be reproduced.Thresholds were noted to be satisfactory.Ts confirmed this indicated that the issue is likely related to the lead-device connection but also suggested continued monitoring of the lead.Rrt was programmed off to optimize device performance.The patient also reported palpitation symptoms.Ts review of electrograms (egm) from the time of the symptoms indicated that the device seemed to be pacing appropriately, no record of a fast rate was found on the egm.The caller reported they would discuss the ts findings with the physician.No adverse patient effects were reported.This device remains in service.
 
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.Additionally, investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.
 
Event Description
It was reported that impedance on the right atrial (ra) channel of this implantable cardioverter defibrillator was high and out of range.The ra lead is from another manufacturer.Oversensing of signals from the respiratory rate trend (rrt) feature were noted on the ra channel.A technical services (ts) consultant discussed turning rrt off and noted that the reported clinical observations could be due to either a lead or a connection issue.Ts also suggested further system evaluation.The patient was seen in clinic and the noise could not be reproduced.Thresholds were noted to be satisfactory.Ts confirmed this indicated that the issue is likely related to the lead-device connection but also suggested continued monitoring of the lead.Rrt was programmed off to optimize device performance.The patient also reported palpitation symptoms.Ts review of electrograms (egm) from the time of the symptoms indicated that the device seemed to be pacing appropriately, no record of a fast rate was found on the egm.The caller reported they would discuss the ts findings with the physician.No adverse patient effects were reported.This device remains in service.
 
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Brand Name
DYNAGEN EL ICD DR
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11234135
MDR Text Key228840478
Report Number2124215-2021-02335
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526534829
UDI-Public00802526534829
Combination Product (y/n)N
PMA/PMN Number
P960040/S306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/04/2021
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 Date09/12/2019
Device Model NumberD153
Device Catalogue NumberD153
Device Lot Number209879
Was Device Available for Evaluation? No
Date Manufacturer Received02/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age38 YR
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