MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Capture Threshold (3266)

Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

The product is being evaluated in our post market quality assurance laboratory. This report will be updated when evaluation is complete. (b)(4).

Event Description

It was reported that remote monitoring identified this device was in safety mode. The device reverted to unipolar pacing which resulted in oversensing and pacing inhibition. Additionally, elevated threshold measurements and muscle stimulation were noted. The device was explanted and replaced. No additional adverse patient effects were reported.

Event Description

It was reported that remote monitoring identified this device was in safety mode. The device reverted to unipolar pacing which resulted in oversensing and pacing inhibition. Additionally, elevated threshold measurements and muscle stimulation were noted. The device was explanted and replaced. No additional adverse patient effects were reported. This supplemental report is being filed due to the completed evaluation of this product.

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 while communicating with the latitude remote monitoring system 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. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 11152885
• Report Number: 2124215-2020-28053
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/25/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 106168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial
• Patient Age: 72 YR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention