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

Model Number V173

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

Patient Problem Dyspnea (1816)

Event Date 11/09/2020

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode with limited device functionality.The patient reported shortness of breathe and is therapy dependent.Technical services recommended to replace the device.At this time, this crt-p remains in service.No 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.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 and the reported clinical observations.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode with limited device functionality.The patient reported shortness of breathe and is therapy dependent.Technical services recommended to replace the device.At this time, this crt-p remains in service.No adverse patient effects were reported.This supplemental is being filed as the device was explanted and returned for device analysis details.No additional adverse patient effects were reported.

• 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: 11104569
• MDR Text Key: 224811128
• Report Number: 2124215-2020-25660
• 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
• Report Date: 07/05/2021

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: 11/05/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 01/02/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR