Site
|
Patient
|
AE
|
Complication
|
Event date
|
AE code
|
xxx
|
xxx
|
x
|
|
xx/xx/xxxx
|
xxx
|
Demographic / Medical history
- [age] year old [gender]
- Past Medical History: [eg. CAD, Severe mitral stenosis, former tobacco use, dyslipidemia, ...]
Procedure
- Index Procedure Date/Time: xx/xx/xxxx at xx:xx [insert date and time]
- Index Procedure Detail:
- On [insert date and time] the subject underwent a [select surgical correction] for [select etiology].
- Enter access site details
- Baseline MR severity was classified as [select none, trace, mild, mild-moderate, moderate, moderate-severe-severe] and post-implant MR was classified as [select severity].
- The site reported that there were/were not procedural complication(s).
Event
- Event:
- Site Reported Event Onset Date: xx/xx/xxxx
- Event summary:
- Symptoms and sign: Subject presented with [sign and symptom] on xx/xx/xxxx.
- Important characteristics of the chief complaint such as severity, site, and duration.
- Other important symptoms related to the chief compliant.
- Physical assessment:
- Vital sign
- Positive physical examinations or related negative examinations.
Laboratory data and Imaging
- Lab studies:
- Troponin levels and timing:
Date
|
Time
|
CKMB nl: (ratio)
|
Troponin nl: (ratio)
|
xx/xx/xxx
|
xx:xx
|
|
|
xx/xx/xxx
|
xx:xx
|
|
|
xx/xx/xxx
|
xx:xx
|
|
|
- Other laboratory:
- Date/ name/ value [ as a list ]
Date
|
Time
|
Finding
|
xx/xx/xxx
|
xx:xx
|
|
xx/xx/xxx
|
xx:xx
|
|
xx/xx/xxx
|
xx:xx
|
|
- ECHO/ date:
- Trans-thoracic:
- Trans-esophagus:
- CXR / date:
- Other imaging and diagnostic tests / date:
Consults
Clinical course
Treatment
Outcome
[Discharge / Hospice / Death]