Model Number 429688 |
Device Problems
Decreased Sensitivity (2534); Impedance Problem (2950)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: a2dr01 ipg, implanted (b)(6) 2014; 5086mri58 lead, implanted (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the left ventricular (lv) lead, which is plugged into the right ventricular (rv) port on the implantable pulse generator (ipg), exhibited upward trends in impedance and low amplitude r waves.Follow up yielded no information and the lead remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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