Model Number D152 |
Device Problems
High impedance (1291); Failure to Sense (1559)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/05/2024 |
Event Type
Injury
|
Event Description
|
It was reported that the right atrial (ra) lead of this implantable cardioverter defibrillator (icd) system was suspected to be fractured.High out of range impedance measurements were observed as well.A revision procedure was performed and when attempting to get sensing, this device did not sense the newly implanted atrial lead.The lead was unplugged and sensing was evaluated with the pacing system analyzer (psa) and normal measurements were obtained.The lead was connected to a new device and normal device function was observed.The physician could not determine if the atrial lead was fractured or if it was a device issue.No additional adverse patient effects were reported.It is expected to receive this device for analysis.
|
|
Manufacturer Narrative
|
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Analysis found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.
|
|
Event Description
|
It was reported that the right atrial (ra) lead of this implantable cardioverter defibrillator (icd) system was suspected to be fractured.High out of range impedance measurements were observed as well.A revision procedure was performed and when attempting to get sensing, this device did not sense the newly implanted atrial lead.The lead was unplugged and sensing was evaluated with the pacing system analyzer (psa) and normal measurements were obtained.The lead was connected to a new device and normal device function was observed.The physician could not determine if the atrial lead was fractured or if it was a device issue.No additional adverse patient effects were reported.This device has been received for analysis.
|
|
Search Alerts/Recalls
|