MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, (CRT-P)

Model Number V173

Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)

Event Date 02/02/2020

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room after feeling muscle stimulation.Device interrogation revealed the device was in safety mode.Device replacement was recommended.No adverse patient effects were reported.The device remains in service.

Manufacturer Narrative

The device has not been returned at this time.If the device is returned, analysis will be performed and this report will be updated.

Event Description

Additional information received reported that the device was explanted and replaced with a non boston scientific device.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 is being used to capture the additional intervention performed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Interrogation of the device found it was no longer operating in safety mode and review of device memory did not identify faults or errors that would have resulted in reversion to safety mode.The device casing was removed, and battery analysis identified a high internal resistance.Despite testing and information provided from the field, the cause of the high resistance within the battery cell could not be determined.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room after feeling muscle stimulation.Device interrogation revealed the device was in safety mode.Device replacement was recommended.No adverse patient effects were reported.The device remains in service.Additional information received reported that the device was explanted and replaced with a non boston scientific device.No additional adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room after feeling muscle stimulation.Device interrogation revealed the device was in safety mode.Device replacement was recommended.No adverse patient effects were reported.The device remains in service.Additional information received reported that the device was explanted and replaced with a non boston scientific device.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 is being used to capture the additional intervention performed.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Interrogation of the device found it was no longer operating in safety mode and review of device memory did not identify faults or errors that would have resulted in reversion to safety mode.The device casing was removed, and battery analysis identified a high internal resistance.Despite testing and information provided from the field, the cause of the high resistance within the battery cell could not be determined.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was not operating in safety mode and that brady therapy remained available.There were system resets which occurred during a telemetry session.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9924586
• MDR Text Key: 186746358
• Report Number: 2124215-2020-03476
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2021

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: 05/11/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: 02/02/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 02/14/2020; 10/14/2020; 05/18/2021
• Supplement Dates FDA Received: 04/06/2020; 12/19/2020; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR