Rabindra R Tambyraja1, Michael A Gutman, Cliff A Megerian. 1. Department of Otolaryngology-Head & Neck Surgery, Case Western Reserve University School of Medicine, University Hospitals of Cleveland, Cleveland, OH 44106, USA.
Abstract
OBJECTIVES: To explore the suitability of the Manufacturer User Facility and Distributor Experience (MAUDE) database (which is maintained by the Food and Drug Administration and has a mandatory reporting requirement) for systemic analysis of cochlear implant complications and treatments and, in so doing, analyze trends in cochlear implant complications for 2 periods, 2002 and pre-1998. DATA SOURCES: All events from 2002 and from before 1998 were considered. Events and action taken were categorized and tabulated. DATA SYNTHESIS: Because there was no null hypothesis, statistical analysis (chi2) was only used in comparing the 2 time frames. CONCLUSIONS: Structural limitations of the database, in addition to disparate reporting quality, made systematic analysis difficult. It was noted that spontaneous device failure accounted for the greatest single number of adverse events for both 2002 and the pre-1998 period (267/654 [41%] and 74/129 [57%], respectively), confirming earlier studies. A statistically significant decrease in spontaneous device failure and a significant increase in infections from the pre-1998 period to 2002 was observed. Flap problems ranging from extrusion to infection that required explantation were less frequently reimplanted than other problems requiring explantation, such as device failure or trauma. We considered new directions, including close collaboration with the new MedSun reporting system and conclude that while a valuable resource for narrative data, the current structure of the MAUDE database is only modestly useful for analyzing trends in complications and cannot answer several crucial questions, including device type comparisons. We suggest changing the current report format to include patient age, duration of implant, presence of anatomical abnormalities, and details on spontaneous device failures.
OBJECTIVES: To explore the suitability of the Manufacturer User Facility and Distributor Experience (MAUDE) database (which is maintained by the Food and Drug Administration and has a mandatory reporting requirement) for systemic analysis of cochlear implant complications and treatments and, in so doing, analyze trends in cochlear implant complications for 2 periods, 2002 and pre-1998. DATA SOURCES: All events from 2002 and from before 1998 were considered. Events and action taken were categorized and tabulated. DATA SYNTHESIS: Because there was no null hypothesis, statistical analysis (chi2) was only used in comparing the 2 time frames. CONCLUSIONS: Structural limitations of the database, in addition to disparate reporting quality, made systematic analysis difficult. It was noted that spontaneous device failure accounted for the greatest single number of adverse events for both 2002 and the pre-1998 period (267/654 [41%] and 74/129 [57%], respectively), confirming earlier studies. A statistically significant decrease in spontaneous device failure and a significant increase in infections from the pre-1998 period to 2002 was observed. Flap problems ranging from extrusion to infection that required explantation were less frequently reimplanted than other problems requiring explantation, such as device failure or trauma. We considered new directions, including close collaboration with the new MedSun reporting system and conclude that while a valuable resource for narrative data, the current structure of the MAUDE database is only modestly useful for analyzing trends in complications and cannot answer several crucial questions, including device type comparisons. We suggest changing the current report format to include patient age, duration of implant, presence of anatomical abnormalities, and details on spontaneous device failures.
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