Model Number V273 |
Device Problems
Off-Label Use (1494); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/10/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) underwent an off-label magnetic resonance imaging (mri) scan.The crt-p entered safety mode and reset.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.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) underwent an off-label magnetic resonance imaging (mri) scan.The crt-p entered safety mode and reset.This crt-p was explanted and replaced.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|