SJM Confirm DM2100 DM2102 (ICM)

Conditional

ST. JUDE MEDICAL, INC

Implantable cardiac monitor

Testing has demonstrated that the St. Jude Medical™MR Conditional SJM Confirm™ ICM is conditionally safe for use in the MRI environment when used according to the instructions in this manual. MR Conditional Contraindications  Patients with abandoned cardiac hardware including leads, lead extenders, or lead adaptors are contraindicated for an MRI scan.  Patients with non-MR Conditional implantable devices are contraindicated for an MRI scan.  Patients with a St. Jude Medical™ SJM Confirm™ ICM that has been implanted for less than 6 weeks are contraindicated for an MRI scan. The 6 week post-implant waiting period allows time for the implant pocket and wound to heal which minimizes the effects of "tugging" on the device caused by magnetic fields.

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