Model Number PLATINIUM SONR CRT-D 1841 |
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 07/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Pending.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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The defibrillation system was implanted on (b)(6) 2016.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.Preliminary analysis results did not reveal any device malfunction.
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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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The defibrillation system was implanted on (b)(6) 2016.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.Preliminary analysis results did not reveal any device malfunction.
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Manufacturer Narrative
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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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The defibrillation system was implanted on (b)(6) 2016.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.Preliminary analysis results did not reveal any device malfunction.
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Search Alerts/Recalls
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