Model Number REPLY DR |
Device Problem
Failure to Interrogate (1332)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 11/26/2015 |
Event Type
Injury
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Event Description
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It was reported that it was no possible to interrogate the subject device during the follow-up.There was no answer to the magnet.The device was explanted and was returned for analysis.An investigation is required.
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Manufacturer Narrative
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In previous initial mdr, the awareness date was erroneous.As reported by subsidiaries, it should be (b)(6) 2015.
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Event Description
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It was reported that it was no possible to interrogate the subject device during the follow-up.There was no answer to the magnet.The device was explanted and was returned for analysis.An investigation is required.
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Manufacturer Narrative
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Preliminary analysis of the returned device showed that the electrical characteristics of the returned unit are within specifications.
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Event Description
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It was reported that it was no possible to interrogate the subject device during the follow-up.There was no answer to the magnet.The device was explanted and was returned for analysis.An investigation is required.
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Event Description
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It was reported that it was no possible to interrogate the subject device during the follow-up.There was no answer to the magnet.The device was explanted and was returned for analysis.An investigation is required.
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Search Alerts/Recalls
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