MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE DEVICE

Model Number V173

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

Patient Problems Dizziness (2194); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/09/2020

Event Type  Injury  

Event Description

It was reported that this patients remote communicator displayed a red call doctor icon.It was determined that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in a safety mode.At this time, this crt-p device remains in service.No adverse patient effects were reported.

Event Description

Additional information was received that indicated this cardiac resynchronization therapy pacemaker (crt-p) was explanted and replaced due to the device being in a safety core mode.

Manufacturer Narrative

Patient code 3191 captures the surgical intervention.

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.Review of device memory identified an error that resulted in software resets performed in an attempt to correct an identified inconsistency.The battery was removed and detailed analysis was able to confirm the cell had a high internal resistance.The high internal resistance resulted in the software resets, reversion to safety mode operation.Patient code 3191 captures the surgical intervention.

Event Description

This supplemental report is being filed to include device 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 mode.Review of device memory identified an error that resulted in software resets performed in an attempt to correct an identified inconsistency.The battery was removed and detailed analysis was able to confirm the cell had a high internal resistance.The high internal resistance resulted in the software resets, reversion to safety mode operation.Patient code 3191 captures the surgical intervention.

Event Description

This supplemental report is being filed due to conclusion code update.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10221779
• MDR Text Key: 197343917
• Report Number: 2124215-2020-08155
• 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: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/03/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 82