Model Number T175 |
Device Problem
Defective Device (2588)
|
Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
|
Event Date 01/01/2008 |
Event Type
Injury
|
Manufacturer Narrative
|
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
|
|
Event Description
|
Boston scientific received information that this the patient's implantable cardioverter defibrillator (icd) was turned off but was left in place.This icd remains in service.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient's implantable cardioverter defibrillator (icd) was turned off but was left in place.This icd remains in service.No adverse patient effects were reported.Additional information received indicated that the device has not been working for several years and the leads have actually fractured as the patient has grown.The device together with the leads will be removed.No adverse patient effects were reported.
|
|
Event Description
|
It was reported that the patient's implantable cardioverter defibrillator (icd) was turned off but was left in place.Additional information received indicated that the device has not been working for several years and the leads have actually fractured as the patient has grown.The device together with the leads will be removed.Moreover, during system extraction, it was found out that the patient had a non-boston scientific device.The field representative stated that this icd was replaced at some unknown time.Device and leads were removed from the patient.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
|
|
Search Alerts/Recalls
|