Model Number 103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Information (3190)
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Event Date 07/30/2020 |
Event Type
Injury
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Event Description
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It was reported that the patient was hospitalized due to an unspecified adverse event.No additional relevant information has been received to date.
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Manufacturer Narrative
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B5.Describe event or problem - correction - generator replacement was inadvertently not included on supplemental #1.D7.Explant date - correction - explant date was inadvertently not included on supplemental #1.
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Event Description
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It was reported the patient had a generator replacement occur.The explanted device was discarded.No additional relevant information has been received to date.
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Manufacturer Narrative
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B2.Outcomes attributed to adverse event - correction - "required intervention to prevent permanent impairment/damage" and "other serious" options were not selected in the initial mdr.B5.Describe event - correction - information was not included in initial mdr.H6.Evaluation codes - method - correction - code 4117 was not coded in the initial mdr.
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Event Description
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It is unknown if the event is related to low battery or cardiac issue.No additional relevant information has been received to date.
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Search Alerts/Recalls
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