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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 Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p), exhibited five months longevity from last month and is now in safety mode.Technical services (ts) recommended device replacement as soon as possible, as it appears to be premature battery depletion.Two days later, the crt-p was explanted and replaced with a new device.No additional adverse patient effects were reported.The device has been returned for analysis.This report will be updated upon completion of product analysis.
 
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.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p), exhibited five months longevity from last month and is now in safety mode.Technical services (ts) recommended device replacement as soon as possible, as it appears to be premature battery depletion.Two days later, the crt-p was explanted and replaced with a new device.No additional adverse patient effects were reported.The device has been returned for analysis.This report will be updated upon completion of product analysis.
 
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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 Key12660757
MDR Text Key277261685
Report Number2124215-2021-29786
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 Health Professional
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/25/2016
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number106152
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2014
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) Hospitalization; Required Intervention;
Patient Age82 YR
Patient SexMale
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