Question 1 of 30
MedTech Solutions, a manufacturer of implantable cardiac pacemakers, has recently launched a new model onto the market. After six months of sales, the company\'s post-market surveillance team begins to receive an increasing number of reports from hospitals indicating a higher-than-expected rate of battery depletion in the pacemakers, leading to premature device replacements. The reports include detailed patient information, device serial numbers, and specific measurements of battery voltage over time. According to ISO 13485:2016 requirements for risk management and post-market surveillance, what is the MOST appropriate initial action for MedTech Solutions to take upon receiving this trend of concerning post-market data? The data includes customer feedback, audit results, and process performance. This action should align with maintaining compliance and ensuring patient safety while adhering to the standard\'s focus on continuous improvement and risk mitigation.
Use the post-market surveillance data to update the risk assessment for the pacemaker model and initiate corrective actions to address the battery depletion issue.
Issue a public statement assuring customers that the company is aware of the reports and is investigating the matter, without taking immediate internal action.
Continue monitoring the reports for another six months to confirm the trend before taking any action, as premature action could be costly and disruptive.
Immediately halt production of the pacemaker model and recall all devices currently in the market, regardless of whether they have exhibited battery depletion issues.

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