Module 16 2024

17/10/2024

The basics of risk evaluation

Scenario#2:

The manufacturer of the Deep Brain Electrodes ran a case based PMCF survey to address Annex XIV, Part B of the MDR.

They collected responses from 5 surgeons at 2 healthcare facilities representing 100 cases.

The survey reported that one patient (1%) suffered an intracerebral hemorrhages (bleed within the brain) that required surgical intervention.

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The basics of risk evaluation

Hazard analysis:

• Intracerebral hemorrhage is a known undesirable side effect of using the Deep Brain Electrodes and is listed in the IFU and SSCP

• The rate reported from the PMCF survey is 1%

• The SSCP reports an intracerebral hemorrhage rate of 0.156%, from Deep Brain Electrode studies N=1/640 patients

• The state-of-the-art analysis reported 1% from a meta – analysis combining 30 studies and 2,624 patients

WHAT QUESTIONS WOULD YOU ASK?

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