PMID- 37497812
OWN - NLM
STAT- MEDLINE
DCOM- 20231031
LR  - 20231031
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 42
IP  - 8
DP  - 2023 Nov
TI  - Understanding a decade of safety reporting for sacral neuromodulation in the Food 
      and Drug Administration Manufacturer and User Facility Device Experience 
      database.
PG  - 1655-1667
LID - 10.1002/nau.25248 [doi]
AB  - INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been 
      implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM 
      technology and clinical applications have evolved, with minimal safety updates 
      after initial trials. We aim to provide an updated overview of real-world SNM 
      safety. These insights will guide informed consent, preoperative counseling, and 
      patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User 
      Facility Device Experience (MAUDE) database is a repository for medical device 
      safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword 
      (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was 
      reviewed and categorized by theme. To corroborate our MAUDE database analysis, a 
      legal librarian searched the Public Access to Court Electronic Records (PACER) 
      database, as well as Bloomberg Law's dockets database for all lawsuits related to 
      SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 
      SNM-related adverse events (AEs). The figure illustrates the prevalence of event 
      categories in the random sample. The largest proportion of reports (25.6%) 
      related to a patient's need for assistance with device use, followed by 
      loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 
      32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock 
      reports. Our legal search revealed only four lawsuits: one for patient 
      complications after an SNM device was used off-label, one case of transverse 
      myelitis after implant, one for device migration or poor placement, and the 
      fourth claimed the device malfunctioned requiring removal and causing permanent 
      injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices 
      and very low complication rates as seen in the original clinical trials. Our 
      findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM 
      "complications" are not AEs, per se, but rather reflect a need for improved 
      technical support or more comprehensive informed consent to convey known device 
      limitations to the patient, such as battery life. Similarly, the number of 
      lawsuits is shockingly low for a device that has been in the market for 24 years, 
      reinforcing the safety of the device. Legal cases involving SNM devices seem to 
      relate to inappropriate patient selection-including at least one case in which 
      SNM was used for a non-FDA approved indication-lack of appropriate follow-up, 
      and/or provider inability to assist the patient with utilizing the device after 
      implantation.
CI  - (c) 2023 The Authors. Neurourology and Urodynamics published by Wiley Periodicals 
      LLC.
FAU - Carlton, Caitlin E
AU  - Carlton CE
AUID- ORCID: 0000-0002-6345-2974
AD  - Department of Urology, University of Texas Southwestern, Dallas, Texas, USA.
FAU - Souders, Colby P
AU  - Souders CP
AD  - Department of Urology, University of Kansas, Kansas City, Kansas, USA.
FAU - Chertack, Nathan A
AU  - Chertack NA
AD  - Department of Urology, University of Texas Southwestern, Dallas, Texas, USA.
FAU - Goueli, Ramy S
AU  - Goueli RS
AD  - Department of Urology, University of Texas Southwestern, Dallas, Texas, USA.
FAU - Lemack, Gary E
AU  - Lemack GE
AD  - Department of Urology, University of Texas Southwestern, Dallas, Texas, USA.
FAU - Anger, Jennifer T
AU  - Anger JT
AUID- ORCID: 0000-0002-7688-4688
AD  - Department of Urology, University of California San Diego, San Diego, California, 
      USA.
FAU - McClelland, Lynn
AU  - McClelland L
AD  - School of Law, University of California Los Angeles, Los Angeles, California, 
      USA.
FAU - Carmel, Maude E
AU  - Carmel ME
AUID- ORCID: 0000-0003-1495-0448
AD  - Department of Urology, University of Texas Southwestern, Dallas, Texas, USA.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20230727
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
SB  - IM
MH  - United States
MH  - Humans
MH  - United States Food and Drug Administration
MH  - *Electric Stimulation Therapy/adverse effects
MH  - Databases, Factual
OTO - NOTNLM
OT  - FDA
OT  - Interstim
OT  - MAUDE
OT  - adverse
OT  - lawsuit
OT  - neuromodulation
OT  - safety
EDAT- 2023/07/27 13:10
MHDA- 2023/10/31 06:42
CRDT- 2023/07/27 07:23
PHST- 2023/05/26 00:00 [revised]
PHST- 2023/03/16 00:00 [received]
PHST- 2023/07/06 00:00 [accepted]
PHST- 2023/10/31 06:42 [medline]
PHST- 2023/07/27 13:10 [pubmed]
PHST- 2023/07/27 07:23 [entrez]
AID - 10.1002/nau.25248 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2023 Nov;42(8):1655-1667. doi: 10.1002/nau.25248. Epub 2023 Jul 
      27.