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

Model Number V173

Device Problems Pacing Problem (1439); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2019

Event Type  Injury  

Event Description

It was reported that this pacemaker patient presented to the emergency room due to an unknown reason, and there was an observed flatline on the egm longer than two seconds.A field representative came to the hospital and interrogated with a programmer, where it was found that the device had three memory errors that put it into safety mode.The device was operating at vvi 72.5ppm, and the sensing was unipolar while in safety core.It was unknown if the patient had any radiation or other procedures.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.The device was returned for analysis.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 core, and review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.Device testing was performed, where normal device function was observed.The cause of the memory inconsistency was not able to be determined through laboratory testing.

Event Description

This report is being filed with analysis details.

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 core, and review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.Additional battery testing was performed and able to identify that the cathode insulation tube was torn, which was determined to the cause for the memory inconsistency.

Event Description

This report is being filed with additional analysis details.

• 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: 8760897
• MDR Text Key: 150027018
• Report Number: 2124215-2019-13053
• 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
• Report Date: 01/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/21/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 12/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 88 YR