MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, (CRT-P)

Model Number V173

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

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety mode.The device was interrogated just prior to explant, and was noted to have recorded a code 1007, indicative of capacitor charge time has exceeded the limit.The device was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety mode.The device was interrogated just prior to explant, and was noted to have recorded a code 1007, indicative of capacitor charge time has exceeded the limit.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 was applied to capture the reportable event of surgery.This 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 not operating in safety mode and that brady therapy remained available.There were system resets which occurred during a telemetry session.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.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.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11211821
• MDR Text Key: 228163278
• Report Number: 2124215-2021-01172
• 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: company representative
• 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: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2014
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR