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

Model Number V173

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that cardiac resynchronization therapy pacemaker (crt-p) was explanted and replaced due to premature battery depletion (pbd).It was noted that the patient was pacer dependent.No additional adverse patient effects were reported.

Event Description

It was reported that cardiac resynchronization therapy pacemaker (crt-p) was explanted and replaced due to premature battery depletion (pbd).It was noted that the patient was pacer dependent.No additional adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy pacemaker (crt-p) was returned for analysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.A longevity calculation was completed.Device memory was reviewed and no faults or errors were noted.The device did not trigger elective replacement indicator (eri) and the programmer indicated the device was in doo(r) mode.It was also noted that the device ra sense counter was significantly larger than the rv sense count and there was evidence of 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 doo(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.

• 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: 12620196
• MDR Text Key: 276368655
• Report Number: 2124215-2021-29598
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2017
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 227465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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: 77 YR
• Patient Sex: Female