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

Model Number V173

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2021

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 faults or errors 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 99.7% 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.

• Brand Name: INVIVE
• 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 Key: 12164004
• MDR Text Key: 261444771
• Report Number: 2124215-2021-18914
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/17/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 100858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR