Model Number 1458QL/86 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Heart Failure/Congestive Heart Failure (4446)
|
Event Type
Death
|
Event Description
|
Related manufacturer reference number: 2017865-2023-23224, related manufacturer reference number: 2017865-2023-23226, related manufacturer reference number: 2017865-2023-23227.It was reported that the patient deceased.There is no allegation from a healthcare professional that the death was device related.The cause of death was congestive heart failure and hypertensive heart disease.
|
|
Manufacturer Narrative
|
Further information was requested, but not received.
|
|
Manufacturer Narrative
|
The lead was returned for patient death.As received, a partial lead (only connector portion) was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection of the partial lead found no anomalies except for procedural damage.
|
|
Search Alerts/Recalls
|