FDA 483 - Medtronic Puerto Rico Operations Co. - March 10, 2010

**FDA 483 Summary: Medtronic Puerto Rico Operations Company**

**Inspection Dates:** December 10, 2009 - March 10, 2010 **Location:** Juncos, Puerto Rico **FEI Number:** 3004369318 **Type of Establishment:** Device Manufacturer **Report Issued To:** Manuel A. Santiago, Vice President

**Main Violations/Issues:**

1. **MDR Reporting Delays:** The firm failed to promptly review, evaluate, and investigate complaints that were reportable under the Medical Device Reporting (MDR) requirements. Specific incidents involved the EnRhythm model, where issues like premature battery depletion and device malfunctions during surgery were not reported in a timely manner.

2. **CAPA Management Deficiencies:** Corrective and Preventive Actions (CAPA) investigations were not completed in a timely manner. High-risk CAPA records, such as those concerning multibeam connector defects and battery voltage issues, remained open for extended periods without proper justification or management approval.

3. **Inadequate Complaint Evaluation:** The firm did not adequately evaluate complaints involving potential device failures to meet specifications. This includes issues with high impedance and battery voltage discrepancies leading to premature device explantation.

**Regulatory Framework:** The observations are based on the FDA's quality system requirements for medical device manufacturers, which mandate timely reporting of adverse events and effective CAPA processes.

**Required Actions:** - Implement prompt and thorough review processes for MDR reportable events. - Expedite CAPA investigations and ensure timely closure with documented justifications. - Enhance complaint evaluation procedures to ensure all potential device failures are adequately assessed.

These observations highlight critical areas for improvement to ensure compliance with FDA regulations and safeguard patient safety.