An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance

American Journal of Therapeutics

Volumn 19, Issue 4, 2012, Pages 248-254

  Laskey, Warren ^a   Awad, Khaled ^a   Lum, Jeremy ^a   Skodacek, Ken ^b   Zimmerman, Barbara ^b   Selzman, Kimberly ^b   Zuckerman, Bram ^b  

^a UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^b CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

device reliability; implantable cardiac devices

Indexed keywords

ARTICLE; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR; DEFIBRILLATOR; DEVICE MALFUNCTION; DEVICE RECALL; DEVICE SAFETY; DEVICES; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; LEGAL ASPECT; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY CONTROL PROCEDURES; RELIABILITY; RISK ASSESSMENT;

CARDIAC RESYNCHRONIZATION THERAPY DEVICES; DEFIBRILLATORS, IMPLANTABLE; EQUIPMENT FAILURE; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84863723090     PISSN: 10752765     EISSN: 15363686     Source Type: Journal    
DOI: 10.1097/MJT.0b013e3182512ca5     Document Type: Article

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