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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 High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/17/2020
Event Type  malfunction  
Manufacturer Narrative
Additional information has been requested.If additional information is received, this report will be updated.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and non boston scientific right atrial (ra) lead exhibited impedance measurements of greater than 3000 ohms, causing the device to emit tones.Additionally, ra noise and oversensing were observed; which appeared to be due to minute ventilation (mv) signal oversensing.The right ventricular (rv) lead intrinsic amplitude measurements were also out of range, exhibited by a non boston scientific rv lead.Boston scientific technical services (ts) discussed programming and troubleshooting options with the health care professional (hcp).No adverse patient effects were reported.The device remains in service.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and non boston scientific right atrial (ra) lead exhibited impedance measurements of greater than 3000 ohms, causing the device to emit tones.Additionally, ra noise and oversensing were observed; which appeared to be due to minute ventilation (mv) signal oversensing.The right ventricular (rv) lead intrinsic amplitude measurements were also out of range, exhibited by a non boston scientific rv lead.Boston scientific technical services (ts) discussed programming and troubleshooting options with the health care professional (hcp).No adverse patient effects were reported.The device remains in service.Additional information received reported that the device was reprogrammed.The lead was thoroughly evaluated which showed no issues.No adverse patient effects were reported.The 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, and 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 this cardiac resynchronization therapy defibrillator (crt-d) and non boston scientific right atrial (ra) lead exhibited impedance measurements of greater than 3000 ohms, causing the device to emit tones.Additionally, ra noise and oversensing were observed; which appeared to be due to minute ventilation (mv) signal oversensing.The right ventricular (rv) lead intrinsic amplitude measurements were also out of range, exhibited by a non boston scientific rv lead.Boston scientific technical services (ts) discussed programming and troubleshooting options with the health care professional (hcp).No adverse patient effects were reported.The device remains in service.Additional information received reported that the device was reprogrammed.The lead was thoroughly evaluated which showed no issues.No adverse patient effects were reported.The device remains in service.
 
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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 Key10225856
MDR Text Key197950556
Report Number2124215-2020-10125
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534614
UDI-Public00802526534614
Combination Product (y/n)N
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/17/2020
Device Model NumberG150
Device Catalogue NumberG150
Device Lot Number492403
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age73 YR
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