Model Number L301 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/15/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that this pacemaker had entered safety mode, and upon interrogation the following codes were observed: 0x0 0x0 0x0.In addition, the battery of this implantable device was suspected to be depleting prematurely.This pacemaker 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.Device telemetry data confirmed it was operating in safety mode and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.
|
|
Event Description
|
It was reported that this pacemaker had entered safety mode, and upon interrogation the following codes were observed: 0x0 0x0 0x0.In addition, the battery of this implantable device was suspected to be depleting prematurely.This pacemaker was explanted and replaced.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|