PMID- 34487571
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20220731
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Print)
IS  - 0733-2467 (Linking)
VI  - 40
IP  - 8
DP  - 2021 Nov
TI  - Magnetic resonance imaging interactions with a sacral neuromodulation system.
PG  - 1862-1868
LID - 10.1002/nau.24756 [doi]
AB  - AIMS: Sacral neuromodulation (SNM) has successfully treated patients with 
      functional urinary and/or bowel disorders for more than two decades. 
      Historically, patients with the InterStim system (Medtronic) were contraindicated 
      for Magnetic Resonance Imaging (MRI) scans. In 2012, Medtronic obtained Food and 
      Drug Administration (FDA) approval for allowing 1.5 Tesla (T) MRI head scans. In 
      September 2019, the Axonics System (Axonics) received FDA approval for 1.5 T 
      full-body MR Conditional labeling and then 3 T full-body MR Conditional labeling 
      in July 2020. In August 2020, Medtronic received 1.5 and 3 T full-body MR 
      Conditional labeling from the FDA for their new SNM systems (InterStim II and 
      Micro devices with SureScan(TM)  leads). With the advancements in MRI technology 
      and availability of full-body MRI eligible SNM systems, it is important for 
      physicians to better understand MRI safety for these systems. METHODS: This paper 
      explains the fundamentals of MRI physics, its interactions with active 
      implantable medical devices (AIMDs), the subsequent potential safety hazards with 
      emphasis on radio frequency (RF)-related safety, and the risks associated with 
      "Off-label" scans, including abandoned and broken leads. RESULTS: MRI guidelines 
      provided by the AIMD device manufacturer should be followed to ensure MRI scan 
      safety and avoid any unnecessary risk to patients. CONCLUSIONS: MRI guidelines 
      provided by the device manufacturer are the best resource for guidance for 
      performing safe MRI scanning. Specific conditions should be fully understood and 
      generalizations on MRI safety claims based on partial analysis or case studies 
      should be avoided.
CI  - (c) 2021 The Authors. Neurourology and Urodynamics published by Wiley Periodicals 
      LLC.
FAU - Huang, Xuechen
AU  - Huang X
AUID- ORCID: 0000-0003-2835-4161
AD  - Axonics Inc., Irvine, CA, USA.
FAU - Jiang, Guangqiang Jay
AU  - Jiang GJ
AUID- ORCID: 0000-0001-6982-6191
AD  - Axonics Inc., Irvine, CA, USA.
LA  - eng
PT  - Journal Article
DEP - 20210906
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
SB  - IM
MH  - *Electric Stimulation Therapy/adverse effects
MH  - Humans
MH  - *Magnetic Resonance Imaging
MH  - Radio Waves
MH  - Sacrococcygeal Region
MH  - Sacrum/diagnostic imaging
PMC - PMC9290516
OTO - NOTNLM
OT  - MRI physics
OT  - implantable neurostimulator
EDAT- 2021/09/07 06:00
MHDA- 2021/11/26 06:00
PMCR- 2022/07/18
CRDT- 2021/09/06 17:10
PHST- 2021/07/01 00:00 [revised]
PHST- 2021/03/14 00:00 [received]
PHST- 2021/07/13 00:00 [accepted]
PHST- 2021/09/07 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2021/09/06 17:10 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - NAU24756 [pii]
AID - 10.1002/nau.24756 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2021 Nov;40(8):1862-1868. doi: 10.1002/nau.24756. Epub 2021 Sep 
      6.