Model Number PLATINIUM 4LV SONR CRT-D 1844 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Information (3190)
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Event Date 07/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by (b)(4) that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, the device was prophylactically replaced on (b)(6) 2018 since the patient was pacing-dependent, as advised in the field safety notice on platinium devices issued in (b)(6) 2018.
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Manufacturer Narrative
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Preliminary analysis did not reveal any device malfunction.The electrical characteristics of the returned device conformed to established specifications.The device involved in this mdr report is not included in any recall reported to fda; field corrected.
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Event Description
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Reportedly, the device was prophylactically replaced on (b)(6) 2018 since the patient was pacing-dependent, as advised in the field safety notice on platinium devices issued in (b)(6) 2018.
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Event Description
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Reportedly, the device was prophylactically replaced on (b)(6) 2018 since the patient was pacing-dependent, as advised in the field safety notice on platinium devices issued in (b)(6) 2018.
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Search Alerts/Recalls
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