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	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited a remote monitoring alert indicating the device reverted to safety mode with limited critical therapy still available, specifically unipolar sensing and pacing at a fixed rate.The healthcare provider (hcp) indicated that this is a new patient to their clinic and noted that other than the safety mode alert message, all remote monitoring data is from the previous remote device interrogation which occurred ten days before the alert.At the time of the previous remote device interrogation, the device had an approximated ten months of battery longevity remaining.The hcp also noted that the patients underlying rhythm is unknown.Boston scientific technical services (ts) discussed safety mode with the hcp, explaining that the cause is unknown until the device is replaced and returned for a detailed analysis.The hcp indicated they will review and discuss this with the physician.The device was subsequently returned to boston scientific, indicating it was explanted.No further information has been provided.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.
Additional Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.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 and 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.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device exhibited a remote monitoring alert indicating the device reverted to safety mode with limited critical therapy still available, specifically unipolar sensing and pacing at a fixed rate.The healthcare provider (hcp) indicated that this is a new patient to their clinic and noted that other than the safety mode alert message, all remote monitoring data is from the previous remote device interrogation which occurred ten days before the alert.At the time of the previous remote device interrogation, the device had an approximated ten months of battery longevity remaining.The hcp also noted that the patients underlying rhythm is unknown.Boston scientific technical services (ts) discussed safety mode with the hcp, explaining that the cause is unknown until the device is replaced and returned for a detailed analysis.The hcp indicated they will review and discuss this with the physician.The device was subsequently returned to boston scientific, indicating it was explanted.No further information has been provided.No additional adverse patient effects were reported.

• 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: 13137278
• Report Number: 2124215-2021-34420
• Device Sequence Number: 1843896
• Product Code: NKE
• UDI-Device Identifier: 00802526536625
• UDI-Public: 00802526536625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 10/24/2014
• Device Model Number: V172
• Device Catalogue Number: V172
• Device Lot Number: 100590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/01/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2018-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male