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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); Low impedance (2285); Device Sensing Problem (2917)
Patient Problems Dizziness (2194); Palpitations (2467)
Event Date 11/20/2018
Event Type  Injury  
Event Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited noise and oversensing on the right ventricular (rv) lead. The patient experienced lightheadedness and palpitations. The noise was recreated with isometrics. In addition, the rv lead impedances were stable around 500 ohms; however, occasionally they were low and out of range measuring less than 200 ohms. Boston scientific technical services (ts) discussed this could be the early stages of a lead insulation breach. Subsequently, a revision procedure was performed and the rv lead was surgically abandoned and replaced. The crt-p remains in service. No additional adverse patient effects were reported.
 
Event Description
This supplemental report is being filed as the conclusion code was updated.
 
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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 CLONMEL LIMITED
cashel road
,
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
,
saint paul, MN 55112
6515826168
MDR Report Key8250122
MDR Text Key133128901
Report Number2124215-2019-00148
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/17/2017
Device Model NumberV273
Device Catalogue NumberV273
Device Lot Number118570
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 Received03/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Treatment Data
Date Received: 01/15/2019 Patient Sequence Number: 1
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