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]

• 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]

• 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]

• Age: [Years]
• Sex: [Male / Female / Other]
• Relevant Medical History:

[Summarize significant comorbidities or past diagnoses.]

• Concomitant Medications:

[List all current medications, dosages, and frequencies.]

• Relationship to Product/Intervention:
  • [ ] Not Related
  • [ ] Unlikely
  • [ ] Possible
  • [ ] Probable
  • [ ] Definite
• Rationale:

[Explain reasoning for causality judgment.]

• [ ] Discontinued product/intervention
• [ ] Dose adjustment
• [ ] Supportive treatment
• [ ] Surgical intervention
• [ ] None
• Describe in detail:

[Explain actions taken in response to the AE.]

• 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.]

Confidential – For internal documentation and regulatory compliance only.