TY - JOUR
T1 - Cochlear implant complications
T2 - Utility of federal database in systematic analysis
AU - Tambyraja, Rabindra R.
AU - Gutman, Michael A.
AU - Megerian, Cliff A.
PY - 2005/3
Y1 - 2005/3
N2 - 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 (χ2) 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 explant were less frequently reimplanted than other problems requiring explant, 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.
AB - 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 (χ2) 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 explant were less frequently reimplanted than other problems requiring explant, 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.
UR - http://www.scopus.com/inward/record.url?scp=14844313651&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=14844313651&partnerID=8YFLogxK
U2 - 10.1001/archotol.131.3.245
DO - 10.1001/archotol.131.3.245
M3 - Article
C2 - 15781766
AN - SCOPUS:14844313651
SN - 0886-4470
VL - 131
SP - 245
EP - 250
JO - Archives of Otolaryngology - Head and Neck Surgery
JF - Archives of Otolaryngology - Head and Neck Surgery
IS - 3
ER -