Model Number CD3231-40Q |
Device Problems
Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Heart Failure (2206); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Based on the information received, the device was prophylactically removed and there is no alleged malfunction of the product.Should the device be returned and the analysis results indicate an anomaly, a follow up report will be submitted.
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Event Description
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Following the advisory for premature battery depletion with implantable cardioverter defibrillator, although there was no eri alert or allegation of premature battery depletion, the device was explanted prophylactically.
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Manufacturer Narrative
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No additional intervention was required.Correct event date is (b)(6) 2017.
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Event Description
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New information states that during unrelated explant procedure, the icd was explanted due to unspecified device failure.Approximately 3 months before the procedure, the patient had heart failure symptoms.Patient was in stable condition after the procedure.Patient is under maximal medical therapy and the symptoms are declining.
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Search Alerts/Recalls
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