BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; IMPLANTABLE PULSE GENERATOR, PACEMAKER (WITH CRT)
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Model Number U125 |
Device Problem
Impedance Problem (2950)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/31/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Based on data analysis of (34) model u125 devices, (8) red alert (right ventricular pacing lead impedance out of range), (30) yellow alert (left ventricular pacing lead impedance out of range), and (49) yellow alert (atrial pacing lead impedance out of range) were identified.The alert dates occurred from december 31, 2015 through june 24, 2019.This investigation will be updated should further information be provided.
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Event Description
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It was reported that boston scientific imagineif team conducted a retrospective data analysis (latitude imagineif data study (phase 2)).Based on data analysis, follow-up patient populations were stratified into two groups with a goal to determine which patients could be followed remotely (computer-based health care) versus those patients that may require in-clinic follow-up.Data from 20,000 (5000 icds, 5000 pacemakers, 5000 crt-p and 5000 crt-d) devices implanted in the united states was collected using latitude nxt and de-identified for analysis.All data was used in accordance with patient confidentiality laws, regulations, and data use agreements.A listing of possible malfunctions or product deficiencies that would satisfy the definition of a complaint were sent to the complaint management center (cmc) for further processing.Red alerts from the patient latitude monitoring are device conditions that could potentially leave the patient without available device therapy.Each individual red alert needs to be assessed by the clinician or physician.Yellow alerts are declared when a certain device condition or patient heart-health issue is detected that may warrant clinician review or investigation.
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Search Alerts/Recalls
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