FDA Form 483 Guidant Corp.

Recipient: Guidant Corp
Product: Insignia Pacemaker

Date: 9/22/05

There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring.

Software used as part of production and the quality system has not been fully validated for its intended use according to an established protocol. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Specifically, the software used to capture the RPR (Return Product Report) data which includes return device tracking, failure analysis information, and failure analysis results has not been verified or validated in regards to missing RPR records. There are [Redacted] missing records for which the firm cannot account for the details of the contents of the deleted record, who deleted the record, or why was the record deleted. The RPR records are part of a full e-records system. There are no hardcopy records of the deleted records.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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