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

Model Number V273

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 08/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been returned at this time.If it is returned, analysis will be performed and this report will be updated.

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room due to phrenic nerve stimulation.The device was found to be operating in safety mode.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room due to phrenic nerve stimulation.The device was found to be operating in safety mode.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 is being used to capture the additional intervention performed.The device has not been returned at this time.If it is returned, analysis will be performed and this report will be updated.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode due to system resets.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session and caused the device to enter safety mode.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 and subsequent reversion to safety mode operation.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: INTUA
• 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
• MDR Report Key: 10621732
• MDR Text Key: 209639479
• Report Number: 2124215-2020-17894
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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: 08/07/2016
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 101041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR