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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 Premature Discharge of Battery (1057); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Resultor Readings (1535); Battery Problem (2885)
Patient Problems Bradycardia (1751); Cardiac Arrest (1762)
Event Date 06/20/2021
Event Type  Injury  
Manufacturer Narrative
The available information indicates that this cardiac resynchronization therapy pacemaker (crt-p) was discarded and will not be returned. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode and was nearing elective replacement indicator (eri). Telemetry revealed oversensing and pacing inhibition with asystole lasting greater than two seconds. The patient was admitted to the hospital. It was noted that the patient had coded the next day; the physician was unsure whether this was related to the observed pacing inhibition. The crt-p was explanted, and replaced. No additional adverse patient effects were reported.
 
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Brand NameINTUA
Type of DevicePULSE 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 Key12243346
MDR Text Key264042087
Report Number2124215-2021-21673
Device Sequence Number1
Product Code NKE
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,health
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/08/2015
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number100197
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
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