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

Model Number V173

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Dyspnea (1816); Discomfort (2330)

Event Date 09/08/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that this device was not available for return.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and the remote monitoring system exhibited an alert which was later found to be due to the device operating in safety mode.The patient reported feeling short of breath and having a rapid pulse.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

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 while communicating with the latitude remote monitoring system 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.It was noted that this device was not available for return.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and the remote monitoring system exhibited an alert which was later found to be due to the device operating in safety mode.The patient reported feeling short of breath and having a rapid pulse.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, IMPLANTABLE, WITH CRT-P
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11356214
• MDR Text Key: 232840301
• Report Number: 2124215-2021-03169
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/03/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR