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

Model Number	V172
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode with limited functionality.Technical services recommended to replace and send back the device.At this time, the device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode with limited functionality.Technical services recommended to replace and send back the device.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 cardiac resynchronization therapy pacemaker (crt-p) was explanted and replaced successfully.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode with limited functionality.Technical services recommended to replace and send back the device.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 cardiac resynchronization therapy pacemaker (crt-p) was explanted and replaced successfully.No additional adverse patient effects were reported.
Additional 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 during a telemetry session which 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.The product has been received for analysis.This report will be updated upon completion of analysis.

• Brand Name: INVIVE
• Common Device Name: 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: 12114382
• Report Number: 2124215-2021-17965
• Device Sequence Number: 3411330
• Product Code: NKE
• UDI-Device Identifier: 00802526536625
• UDI-Public: 00802526536625
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/30/2014
• Device Model Number: V172
• Device Catalogue Number: V172
• Device Lot Number: 100200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 11/03/2021
• Initial Report FDA Received Date: 07/04/2021
• Supplement Report FDA Received Date: 10/10/2021; 01/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female