Outcomes Before and After the Recall of a Heart Failure Pacemaker

Area of Science:

• Cardiology
• Biomedical Engineering
• Public Health

Background:

• Timely disclosure of medical device defects is crucial for patient safety.
• This study examines a specific cardiac resynchronization therapy pacemaker recall.

Purpose of the Study:

• To evaluate the timeliness and completeness of manufacturer recommendations after a medical device recall.
• To assess the adequacy of information provided to patients and physicians for managing patient care.
• To determine the appropriateness of actions taken by the US Food and Drug Administration (FDA).

Main Methods:

• Retrospective case series of 90 patients implanted with a recalled pacemaker.
• Analysis of returned product reports from the Manufacturer and User Facility Device Experience (MAUDE) database.
• Inclusion of data from May 2003 to January 2011 for patient implantation and January 2008 to December 2018 for MAUDE data.

Main Results:

• Five patients experienced syncope due to pacemaker failure before the November 2015 recall.
• Manufacturer and FDA were aware of defects for 19 months prior to recall; wire connection issue omitted from advisory.
• Recall classified as Class II by FDA, despite association with serious adverse events including one death and one cardiac arrest.

Conclusions:

• The pacemaker recall was delayed, and communications lacked critical safety information.
• Findings suggest a need for improved medical device recall management by industry and the FDA.
• Reforms are needed to ensure timely and complete disclosure of medical device defects.