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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 Problem Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2023
Event Type  malfunction  
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) detected out-of-range impedance measurements on the right ventricular (rv) lead.Technical services was consulted and provided lead troubleshooting recommendations.No adverse patient effects were reported.Of note, the rv lead is a non-boston scientific product.The crt-d remains in service.
 
Event Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) detected out-of-range impedance measurements on the right ventricular (rv) lead.Technical services was consulted and provided lead troubleshooting recommendations.No adverse patient effects were reported.Of note, the rv lead is a non-boston scientific product.The crt-d 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 this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the event description for more information regarding the specific circumstances of this event.Investigation has determined 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.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key16225509
MDR Text Key308567912
Report Number2124215-2023-02421
Device Sequence Number1
Product Code NIK
UDI-Device Identifier00802526534553
UDI-Public00802526534553
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P010012/S341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/05/2018
Device Model NumberG141
Device Catalogue NumberG141
Device Lot Number116446
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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