Model Number CD3369-40Q |
Device Problem
Misconnection (1399)
|
Patient Problem
Dizziness (2194)
|
Event Date 12/10/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The results, method, and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
Related manufacturer reference number: 2938836-2019-17756; 2938836-2019-17755.It was reported that the patient presented to the hospital with dizziness and bradycardia.Upon interrogation of the device, high thresholds were observed on the right ventricular (rv) and left ventricular (lv) leads.Intermittent loss of capture was also noted on the rv lead.Programming changes could not be performed.The patient was transferred to a different hospital where the rv and lv leads were explanted and replaced.During the procedure, the set screw could not be tightened in the device header and the new leads could not be secured.The physician decided to explant and replace the device as well.The patient is stable.
|
|
Manufacturer Narrative
|
The reported field event of a set screw anomaly was confirmed in the laboratory.The right ventricular set screw was found to be stripped.A test lead was used on the device and no anomalies were noted.The device was tested on the bench and no anomalies were found.The cause of the set screw anomaly was due to damage sustained during the surgical procedure.
|
|
Search Alerts/Recalls
|