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

Model Number V173

Device Problems Difficult to Remove (1528); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received a supplemental report will be submitted.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker was explanted due to being on an advisory.It was noted that during the procedure, the right ventricular lead was found to be stuck in the header of the device, requiring the use of bone cutters to remove.The lead was successfully removed and used with the new device that was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Pacing and sensing functions were tested and the device was verified to operate as expected.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 also noted that the device sensed in the atrial chamber (b)(4) 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

It was reported that this cardiac resynchronization therapy pacemaker was explanted due to being on an advisory.It was noted that during the procedure, the right ventricular lead was found to be stuck in the header of the device, requiring the use of bone cutters to remove.The lead was successfully removed and used with the new device that was implanted.No additional adverse patient effects were reported.

• 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: 12620223
• MDR Text Key: 276356288
• Report Number: 2124215-2021-20277
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 105529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 03/02/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female