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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number N160
Device Problems Device Alarm System (1012); High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2022
Event Type  malfunction  
Event Description
It was reported that the patient with this implantable cardioverter-defibrillator cardiac resynchronization therapy defibrillator (crt-d) displayed alert due to high out-of-range shock impedance measurements on the right ventricular (rv) lead.Which led to this crt-d exhibiting beep tones.The health care professional (hcp) reached out to technical services (ts) for review and consultation of the date of this patient.Upon review, ts discussed possible causes and provided troubleshooting options.The hcp indicated that this patient is going to continue to monitor remotely.At this time, the product remains in service and no adverse patient effects were reported.
 
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 there was no conclusive evidence that the observed out-of-range impedance measurements were due to a malfunction or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a malfunction or an inadequate lead-to-device connection are likely the result of the low-energy test signal utilized for daily automatic or in-clinic commanded shock lead impedance testing.A software update was released in 2015 to further improve consistency of the impedance test results and provide the clinician with additional diagnostic tools, including programmable shock lead impedance alert limits.
 
Event Description
It was reported that the patient with this implantable cardioverter-defibrillator cardiac resynchronization therapy defibrillator (crt-d) displayed alert due to high out-of-range shock impedance measurements on the right ventricular (rv) lead.Which led to this crt-d exhibiting beep tones.The health care professional (hcp) reached out to technical services (ts) for review and consultation of the date of this patient.Upon review, ts discussed possible causes and provided troubleshooting options.The hcp indicated that this patient is going to continue to monitor remotely.At this time, the product remains in service and no adverse patient effects were reported.
 
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Brand Name
INCEPTA CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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 Key14570345
MDR Text Key293276625
Report Number2124215-2022-18896
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526480997
UDI-Public00802526480997
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010012/S255
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/02/2016
Device Model NumberN160
Device Catalogue NumberN160
Device Lot Number963872
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age54 YR
Patient SexMale
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