Model Number V173 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
|
Patient Problems
Fall (1848); Syncope/Fainting (4411); Limb Fracture (4518)
|
Event Date 09/27/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The product has been received for analysis.This report will be updated upon completion of analysis.
|
|
Event Description
|
It was reported that this patient with a cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room due to having a syncope episode in which the patient fell and fractured his hip.Upon examination, this device was found to be in safety mode.Additionally, the device was depleted and could not be interrogated.Subsequently, the device was explanted and replaced successfully.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.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session 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 patient with a cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room due to having a syncope episode in which the patient fell and fractured his hip.Upon examination, this device was found to be in safety mode.Additionally, the device was depleted and could not be interrogated.Subsequently, the device was explanted and replaced successfully.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|