Model Number 429878 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Muscle Stimulation (1412); Dyspnea (1816); Muscle Spasm(s) (1966); Pneumothorax (2012)
|
Event Date 11/30/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: 693565 lead, implanted: unknown.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that following implant the patient complained of dyspnea and diaphragm spasms.An apical pneumothorax was found, which was successfully resolved by drainage.The leads remain in use.The patient is a participant in adaptresponse clinical study.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was further reported it was a left sided pneumothorax.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was further reported that the patient experienced diaphragmatic stimulation from the left ventricular (lv) lead.The lead was reprogrammed and remains in use.
|
|
Search Alerts/Recalls
|