Model Number V173 |
Device Problems
Off-Label Use (1494); Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)
|
Event Date 01/12/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The product has been received for analysis.This report will be updated upon completion of analysis.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.The device as nearing elective replacement indicator (eri) and the patient had weekly radiation treatments on the right side of her neck.The patient was also experiencing diaphragmatic stimulation.It was noted that the patient was pacer dependent.This crt-p was explanted and replaced.No additional adverse patient effects were reported.
|
|
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.The system resets 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 Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had entered safety mode.The device was nearing elective replacement indicator (eri) and the patient had weekly radiation treatments on the right side of her neck.The patient was also experiencing diaphragmatic stimulation.It was noted that the patient was pacer dependent.This crt-p was explanted and replaced.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|