MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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Model Number W4TR01 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2016.5076-58 lead, implanted: (b)(6).5867-3m adaptor, implanted: (b)(6) 2018.429888 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 the interrogation report showed invalid trend data.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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Product event 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 cardiac compass data was missing/invalid.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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