MEDTRONIC EUROPE SARL SOLARA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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Model Number W4TR06 |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: 5076-52,lead, implanted: (b)(6) 2019.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 there was an increase in left ventricular (lv) lead thresholds.The left ventricular (lv) lead remains in use.It was also reported that the cardiac resynchronization therapy pacemaker (crt-p) exhibited invalid trending data.The device is still in use.Follow up yielded no information.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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