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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 Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to the safety core advisory letter, but did not exhibit advisory behavior.During the explant procedure, the non-boston scientific right ventricular (rv) lead was stuck in the crt-p header, and was difficult to remove.The physician completely removed the setscrew and used considerable mineral oil to successfully remove the lead.A new device of a different model was successfully implanted.The crt-p and wrench with setscrew was returned and analysis is pending.This report will be updated with pertinent information upon completion of device analysis.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to the safety core advisory letter, but did not exhibit advisory behavior.During the explant procedure, the non-boston scientific right ventricular (rv) lead was stuck in the crt-p header, and was difficult to remove.The physician completely removed the setscrew and used considerable mineral oil to successfully remove the lead.A new device of a different model was successfully implanted.The crt-p and wrench with setscrew was returned and analysis is pending.This report will be updated with pertinent information upon completion of device analysis.
 
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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 Key14806955
MDR Text Key294783444
Report Number2124215-2022-22809
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 Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/17/2017
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number118639
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age96 YR
Patient SexMale
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