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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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BOSTON SCIENTIFIC CORPORATION INTUA; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V273
Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Bradycardia (1751)
Event Date 11/06/2021
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker was found to be in safety mode.During the device replacement procedure there was pacing inhibition observed.It was noted that the non boston scientific right ventricular (rv) lead exhibited loss of capture.Subsequently, the device was explanted and replaced due to premature battery depletion and the rv lead was surgically abandoned.The new device and rv lead remain in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The returned cardiac resynchronization therapy pacemaker 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, 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.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode due to system resets.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session and caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.The returned cardiac resynchronization therapy pacemaker 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, 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 pacemaker was found to be in safety mode.During the device replacement procedure there was pacing inhibition observed.It was noted that the non boston scientific right ventricular (rv) lead exhibited loss of capture.Subsequently, the device was explanted and replaced due to premature battery depletion and the rv lead was surgically abandoned.The new device and rv lead remain in service.No additional adverse patient effects were reported.The returned cardiac resynchronization therapy pacemaker 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, 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.
 
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Brand Name
INTUA
Type of Device
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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 Key13262124
MDR Text Key283964190
Report Number2124215-2021-36374
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536670
UDI-Public00802526536670
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/06/2016
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number100665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2014
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 Outcome(s) Required Intervention; Hospitalization;
Patient Age72 YR
Patient SexFemale
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