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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number V173
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 02/16/2021
Event Type  malfunction  
Manufacturer Narrative
A longevity calculation was completed and it was confirmed that the device did not meet longevity expectations. Device memory was reviewed and no suspicious faults or resets were noted. It was confirmed that the device was in ddd mode at the time the replacement indicator was declared. It was also noted that the device sensed in the atrial chamber 100% of the time while implanted with prolonged high atrial rates. 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. Chronic high atrial rates, as occurred with this device, can reduce longevity in devices that are programmed ddd(r) with atrial sensing on. Device power consumption increases proportional to the additional processing for sensed atrial events. As a result, the high rate of atrial sensing was determined to be the cause of the longevity being lower than expected.
 
Event Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects. The returned device was analyzed and the product investigation result indicated that this device exhibited chronic high atrial sensing which affected the longevity.
 
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Brand NameINVIVE
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 Key11781410
MDR Text Key249216739
Report Number2124215-2021-12549
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 05/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/21/2015
Device Model NumberV173
Device Catalogue NumberV173
Device Lot Number103796
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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