Complaint and Adverse Event Reporting Process

True or False. All routine reprogramming sessions should be reported as complaints even when the reprogramming leads to patients leaving the office with functional stimulation.

False

True or False. When a patient says they cannot recharge this is ALWAYS considered to be a complaint.

False

True or False. Explanted product does NOT need to be returned if there is NOT a complaint.

True

True or False. St. Jude Medical is required by the FDA and ISO regulations to fully evaluate all complaints, file regulatory reports (MDR, Vigilance), and monitor and trend complain data to identify issues.

True

True or False. St. Jude Medical's mandate to perform investigation of customer complaints supersedes HIPPA privacy restrictions and permits disclosure for post-marketing surveillance.

True

True or False. Violations of the complaint policy can result in disciplinary action up to and including suspension and termination.

True

What is an adverse event?

Any undesirable experience associated with the use of a medical product in a patient.

FDA definition of complaint

Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

If there is a complaint with the product external product and any explanted product, it must be returned within _______.

3 business days

What is NOT considered a complaint?

- comments about the learning/usage process - statements about whether the device will meet the user's needs and whether it was an improvement of previous versions - statement of preference for one device over another

If a reprogramming meets the patients needs, is it considered a complaint?

No

If there is NOT a complaint associated with the product, does the product still need to be returned.

No

Who do you report adverse events and complaints to?

Technical Services

Is a reprogramming considered a complaint if it is NOT meeting the patient's needs or a deficiency of the device is discovered?

Yes

How long do you have to report the adverse event or complaint?

within 48 hours of awareness