Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION INTUA; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V273
Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 05/06/2022
Event Type  Injury  
Event Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency department for phrenic nerve simulation.It was noted that the device displayed safety mode.Subsequently, the device was explanted due to muscle and pocket stimulation.A new device was implanted and remains in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The device has been returned for analysis.A supplemental report will be filed at the time of completion.
 
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 the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency department for phrenic nerve simulation.It was noted that the device displayed safety mode.Subsequently, the device was explanted due to muscle and pocket stimulation.A new device was implanted and remains in service.No additional adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
4100 hamline avenue north
saint paul MN 55112 5798
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key14537045
MDR Text Key293150879
Report Number2124215-2022-17061
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 06/16/2022
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 Date07/29/2015
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number100436
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2022
Initial Date FDA Received05/28/2022
Supplement Dates Manufacturer Received06/16/2022
Supplement Dates FDA Received06/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2013
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 Age96 YR
Patient SexMale
-
-