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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G141
Device Problems Premature Discharge of Battery (1057); Noise, Audible (3273)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 12/29/2019
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones.The device reached explant indicator earlier than expected.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.No adverse patient effects were reported.The device remains in service.
 
Event Description
Additional information received reported that the device was explanted and replaced.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.Patient code 3191 is being used to capture the additional intervention performed.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was emitting tones.The device reached explant indicator earlier than expected.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.No adverse patient effects were reported.The device remains in service.Additional information received reported that the device was explanted and replaced.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Patient code 3191 is being used to capture the additional intervention performed.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed no anomalies.Although the device memory diagnostics demonstrated that the daily battery voltage measurements displayed an irregular pattern of discharge, the battery voltage level upon receipt in the laboratory was sufficient to ensure therapy availability/delivery while the device was implanted.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.A normal current drain was observed within the circuitry.Collectively, the pattern of irregular daily battery voltage measurements in conjunction with normal power levels and device hybrid current draw is consistent with behavior of devices where a latent current leakage path has occurred within the battery itself, resulting in a partial depletion of the battery.
 
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Brand Name
INOGEN 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 Key9921084
MDR Text Key186338676
Report Number2124215-2020-00161
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534553
UDI-Public00802526534553
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 09/30/2020
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 Date02/10/2018
Device Model NumberG141
Device Catalogue NumberG141
Device Lot Number114600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Initial Date Manufacturer Received 01/02/2020
Initial Date FDA Received04/03/2020
Supplement Dates Manufacturer Received01/07/2020
07/31/2020
Supplement Dates FDA Received04/06/2020
09/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
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