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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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BOSTON SCIENTIFIC CORPORATION INVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problems Over-Sensing (1438); Pacing Problem (1439)
Patient Problem Insufficient Information (4580)
Event Date 04/12/2021
Event Type  malfunction  
Event Description
6 months battery life remaining, the device went into a safety mode; whereby it reprogrammed to vvi at 72bpm, with unipolar sensing and pacing. There is no clear mechanisms as to why this transpired and the device is no longer programmable. In the setting of ventricular unipolar sensing, there was oversensing and resulting pacing inhibition. Need for urgent device replacement.
 
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Brand NameINVIVE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11731489
MDR Text Key247556194
Report Number11731489
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV173
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2021
Event Location Hospital
Date Report to Manufacturer04/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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