Model Number PLATINIUM CRT-D 1711 |
Device Problems
Nonstandard Device (1420); No Apparent Adverse Event (3189)
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Patient Problem
No Information (3190)
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Event Date 10/15/2018 |
Event Type
Injury
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Event Description
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On (b)(6) 2018, the subject device was prophylactically replaced due to the fsn on platinium devices sent in (b)(6) 2018.The use of the subject device was discontinued and it was explanted from the patient¿s body.A new crt-d was connected to the implanted leads in use and the prophylactic crt-d replacement procedure was finished.
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Manufacturer Narrative
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Please refer to the attached analysis report.
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Event Description
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On (b)(6) 2018, the subject device was prophylactically replaced due to the fsn on platinium devices sent in (b)(6) 2018.The use of the subject device was discontinued and it was explanted from the patient¿s body.A new crt-d was connected to the implanted leads in use and the prophylactic crt-d replacement procedure was finished.
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Search Alerts/Recalls
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