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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 Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2020
Event Type  Injury  
Event Description
It was reported that while the patient was in the hospital for ventricular tachycardia (vt) below the rate cut off, the field representative noted oversensing of noise on the right ventricular (rv) pace sense channel that led to pacing inhibition with asystole greater than two seconds on multiple episodes.Noise was also observed on the shock channel.Boston scientific technical services (ts) was consulted and discussed the situation.It was noted the patient had an escape rate of 38 bpm during the current interrogation.The patient was ischemic due to the slow vt.They initially reprogrammed the shock zones and duration.However they eventually programmed the implantable cardioverter defibrillator (icd) to electrocautery mode and put the patient in a life vest.A revision procedure was performed where the rv lead was surgically abandoned and the icd was explanted.A new icd and rv lead were successfully implanted.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.(b)(4).
 
Event Description
It was reported that while the patient was in the hospital for ventricular tachycardia (vt) below the rate cut off, the field representative noted oversensing of noise on the right ventricular (rv) pace sense channel that led to pacing inhibition with asystole greater than two seconds on multiple episodes.Noise was also observed on the shock channel.Boston scientific technical services (ts) was consulted and discussed the situation.It was noted the patient had an escape rate of 38 bpm during the current interrogation.The patient was ischemic due to the slow vt.They initially reprogrammed the shock zones and duration.However they eventually programmed the implantable cardioverter defibrillator (icd) to electrocautery mode and put the patient in a life vest.A revision procedure was performed where the rv lead was surgically abandoned and the icd was explanted.A new icd and rv lead were successfully implanted.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
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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 Key11220652
MDR Text Key241237718
Report Number2124215-2021-01455
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 company representative
Type of Report Initial,Followup
Report Date 02/21/2021
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 Date11/20/2017
Device Model NumberG141
Device Catalogue NumberG141
Device Lot Number113420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Initial Date Manufacturer Received 10/08/2020
Initial Date FDA Received01/24/2021
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received02/21/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age82 YR
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