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Recall Observatory FDA recall evidence

Device product

ESSENTIO MRI DR Pacemaker

Z-0370-2018

December 07, 2017

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 78787
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0370-2018

Official wording

Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

Code information: Model L111

Distribution pattern: AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

Field note

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