====== Adverse Event Report ======

**Patient Identifier:** %%[Use anonymized code]%%
**Date of Report:** %%[YYYY-MM-DD]%%
**Reporter Name/Role:** %%[e.g., Dr. Juan Sales – Neurosurgeon]%%
**Institution:** %%[e.g., General University Hospital Alicante]%%

===== 1. Adverse Event Description =====
  * **Event Title:** %%[Brief summary, e.g., Seizure after DBS lead implantation]%%
  * **Date/Time of Onset:** %%[YYYY-MM-DD, HH:MM]%%
  * **Detailed Description:**  
    %%[Describe the AE in detail, including symptoms, clinical findings, and progression.]%%
  * **Outcome:**  
    * [ ] Recovered  
    * [ ] Recovering  
    * [ ] Not Recovered  
    * [ ] Permanent Damage  
    * [ ] Death  
    * [ ] Unknown  
  * **Date of Resolution (if applicable):** %%[YYYY-MM-DD]%%

===== 2. Product / Intervention Involved =====
  * **Product/Device Name:** %%[e.g., Medtronic Percept PC]%%
  * **Type:** %%[e.g., Implantable Neurostimulator]%%
  * **Lot / Serial Number:** %%[if available]%%
  * **Dosage / Settings:** %%[if medication or programmable device]%%
  * **Date of Use/Implantation:** %%[YYYY-MM-DD]%%

===== 3. Patient Background =====
  * **Age:** %%[Years]%%
  * **Sex:** %%[Male / Female / Other]%%
  * **Relevant Medical History:**  
    %%[Summarize significant comorbidities or past diagnoses.]%%
  * **Concomitant Medications:**  
    %%[List all current medications, dosages, and frequencies.]%%

===== 4. Causality Assessment =====
  * **Relationship to Product/Intervention:**  
    * [ ] Not Related  
    * [ ] Unlikely  
    * [ ] Possible  
    * [ ] Probable  
    * [ ] Definite  
  * **Rationale:**  
    %%[Explain reasoning for causality judgment.]%%

===== 5. Action Taken =====
  * [ ] Discontinued product/intervention  
  * [ ] Dose adjustment  
  * [ ] Supportive treatment  
  * [ ] Surgical intervention  
  * [ ] None  
  * **Describe in detail:**  
    %%[Explain actions taken in response to the AE.]%%

===== 6. Regulatory Reporting =====
  * **Reported to National Authority:** [ ] Yes [ ] No  
  * **Date of Submission:** %%[YYYY-MM-DD]%%
  * **Reference Number (if any):** %%[Insert if received]%%
  * **Additional Notes or Follow-up Plans:**  
    %%[Include monitoring strategies, further tests, or committee reviews planned.]%%

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''Confidential – For internal documentation and regulatory compliance only.''