MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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Model Number W4TR01 |
Device Problems
Unable to Obtain Readings (1516); Reset Problem (3019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 459888 lead, implanted: (b)(6) 2018; 407652 lead, implanted: (b)(6) 2018.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 a remote monitoring transmission showed an alert for a diagnostic reset, and that the ventricular sensing episode list had invalid data.The patient is to have an in-clinic evaluation done to update necessary software, and the device 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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Manufacturer Narrative
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Evaluation summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a software error.Analysis of the device memory indicated that the atrial and ventricular rate histogram data were missing/invalid.Analysis of the device memory indicated the battery measurement was not available.Analysis of the device memory indicated an issue with missing/invalid diagnostic data.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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