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

Model Number V173

Device Problems Pocket Stimulation (1463); Inappropriate or Unexpected Reset (2959)

Patient Problems Undesired Nerve Stimulation (1980); No Code Available (3191)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.

Event Description

It was reported that this device reverted to safety mode following three non-recoverable resets within a 48 hour timeframe.The device was explanted and returned for testing.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual examination identified no anomalies.A review of the device memory noted that a system fault code had been generated which resulted in the device going into safety mode.The device case was removed to facilitate inspection of the internal components and further testing.The battery was removed from the device and replaced with an external power source.The current drain was measured and found to be normal.Detailed analysis of the battery identified an internal short.The short resulted in the clinically-observed fault code and reversion to safety mode.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.The 3191 code was utilized due to the surgery that occurred.

Event Description

This supplemental report is being filed due to the completed evaluation of this product.

Event Description

This supplemental report is being filed to update the evaluation conclusion code and additional manufacturing narrative.

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 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.

• 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
• MDR Report Key: 10221654
• MDR Text Key: 197285198
• Report Number: 2124215-2020-07762
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2021

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: 04/03/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 05/18/2021
• Supplement Dates FDA Received: 12/19/2020; 06/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR