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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 04/11/2021
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during routine check.It was reported that on the external telemetry monitor a fifteen second pause was observed.It was recommended that this device be replaced and the patient have external pacing support until device replacement.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.
 
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.The system resets occurred during a telemetry session 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.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during routine check.It was reported that on the external telemetry monitor a fifteen second pause was observed.It was recommended that this device be replaced and the patient have external pacing support until device replacement.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.
 
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Brand Name
INVIVE
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 Key12112477
MDR Text Key260025398
Report Number2124215-2021-10101
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526536632
UDI-Public00802526536632
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/06/2022
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 Date03/24/2016
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number106081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Initial Date Manufacturer Received 04/11/2021
Initial Date FDA Received07/02/2021
Supplement Dates Manufacturer Received10/07/2021
Supplement Dates FDA Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2016-2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age86 YR
Patient SexFemale
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