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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 Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2023
Event Type  Injury  
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) system presented to the emergency room (er) with intermittent pacing inhibition, and external pacing pads and a transvenous pacing wire were placed.It was determined that the crt-p had entered safety mode, and device interrogation noted the following codes: 0x40 0x0 0x0.The next day, this crt-p was explanted and replaced.No additional adverse patient effects were reported.This crt-p was returned for analysis.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) system presented to the emergency room (er) with intermittent pacing inhibition, and external pacing pads and a transvenous pacing wire were placed.It was determined that the crt-p had entered safety mode, and device interrogation noted the following codes: 0x40 0x0 0x0.The next day, this crt-p was explanted and replaced.No additional adverse patient effects were reported.This crt-p was returned for analysis.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.-- the returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.There was no telemetry to obtain device data and no safety mode signal was observed.The device case was opened and the battery was removed and forwarded for detailed analysis.The battery passed all testing.Analysis was unable to confirm the root cause of the reported safety mode.
 
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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 Key17946914
MDR Text Key325794342
Report Number2124215-2023-57426
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,Company Representative
Reporter Occupation Physician
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/10/2024
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 Date02/17/2017
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number118545
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/25/2023
Initial Date FDA Received10/16/2023
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received05/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2015
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 Age94 YR
Patient SexMale
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