Model Number CD3265-40Q |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hemothorax (1896); Pleural Effusion (2010); Dizziness (2194)
|
Event Date 09/21/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Event Description
|
It was reported that the patient presented in clinic for follow up.The patient experienced light headedness.Upon interrogation the right ventricular lead exhibited high impedance and high threshold.The lead was explanted and replaced on (b)(6) 2017.During the procedure the distal helix did not retract.The lead possibly passed through superior vena cava leading to small right hemothorax.Small right pleural effusion was confirmed upon ct scan which may have been related to the procedure.Following the advisory for premature battery depletion with implantable cardioverter defibrillator, although there was no eri alert or allegation of premature battery depletion, the device was explanted prophylactically and replaced during the same procedure.The procedure was tolerated well.The patient was stable before, during and after the procedure.
|
|
Manufacturer Narrative
|
Interrogation of the device revealed it was above eri when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).The device is included in the premature battery depletion with implantable cardioverter defibrillator advisory notice issued by st.Jude medical on (b)(4) 2016.
|
|
Search Alerts/Recalls
|