. Author manuscript; available in PMC: 2022 Oct 1.

Published in final edited form as: Neuromodulation. 2020 Dec 11;24(7):1181–1189. doi: 10.1111/ner.13325

Table 5.

Strengths and Weaknesses of a MAUDE Database-Based AE Study.

Strengths	Limitations
Offers real-world insights of AE Extensive data on devices from several manufacturers The database provides information about AE patterns and insights for improving severe outcomes such as death and permanent injury at the population level. Some reports are incomplete, inaccurate, or biased. MAUDE is a part of the FDA’s post-marketing surveillance program. The cost of maintaining the registry is not passed on to the investigators or the patients.	Underreporting of less serious AE The database cannot compare rates between devices The database cannot provide the number of patients treated with a particular device. Therefore, incidence or prevalence rates cannot be calculated. Open access for all investigators to evaluate device-related AE An independent reviewer cannot adjudicate serious AE such as death. Causal relationships between AE and outcomes cannot be ascertained. Certain types of device information (trade secrets) are protected and are not released.

Strengths

Limitations

Offers real-world insights of AE
Extensive data on devices from several manufacturers
The database provides information about AE patterns and insights for improving severe outcomes such as death and permanent injury at the population level.
Some reports are incomplete, inaccurate, or biased.
MAUDE is a part of the FDA’s post-marketing surveillance program. The cost of maintaining the registry is not passed on to the investigators or the patients.

Underreporting of less serious AE
The database cannot compare rates between devices
The database cannot provide the number of patients treated with a particular device. Therefore, incidence or prevalence rates cannot be calculated.
Open access for all investigators to evaluate device-related AE
An independent reviewer cannot adjudicate serious AE such as death.
Causal relationships between AE and outcomes cannot be ascertained.
Certain types of device information (trade secrets) are protected and are not released.