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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION AUTOGEN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G172
Device Problems Premature Discharge of Battery (1057); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2021
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) exhibited a large decrease in estimated battery longevity and emitted beeping tones during routine follow up.This device was noted to have been programmed to an increased output, but was reprogrammed.The device was then explanted and returned for analysis.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.The returned cardiac resynchronization therapy defibrillator (crt-d) was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited a large decrease in estimated battery longevity and emitted beeping tones during routine follow up.This device was noted to have been programmed to an increased output, but was reprogrammed.The device was then explanted and returned for analysis.No additional adverse patient effects were reported.
 
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Brand Name
AUTOGEN
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 Key11356133
MDR Text Key232852787
Report Number2124215-2021-03294
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/02/2018
Device Model NumberG172
Device Catalogue NumberG172
Device Lot Number481952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2021
Initial Date Manufacturer Received 01/20/2021
Initial Date FDA Received02/20/2021
Supplement Dates Manufacturer Received04/27/2021
Supplement Dates FDA Received07/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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