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 Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  Injury  

Event Description

It was reported upon interrogation of this cardiac resynchronization therapy pacemaker (crt-p), the device was found to be in safety mode with limited functionality.Technical services (ts) recommended to replace the device and return it back for device analysis.At this time, the device remains in service.No adverse patient effects were reported.

Event Description

It was reported upon interrogation of this cardiac resynchronization therapy pacemaker (crt-p),the device was found to be in safety mode with limited functionality.Technical services (ts) recommended to replace the device and return it back for device analysis.At this time, the device remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received that this device was explanted and replaced with a competitor device.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12113199
• MDR Text Key: 260427886
• Report Number: 2124215-2021-13890
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

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: 102438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 07/03/2021
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female